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Rituximab and COVID-19 vaccines: Studies begin to answer key questions
Rituximab has presented something of a conundrum for patients taking the monoclonal antibody during the COVID-19 pandemic.
Used to manage a variety of autoimmune diseases and cancers, rituximab acts against CD20 proteins expressed on the surface of B cells, causing B-cell depletion. However, it is this B-cell depletion that may put these patients at greater risk of COVID-19 development, progression to more severe disease, and in-hospital mortality. Evidence for this appears to be mixed, with studies showing both that patients using rituximab to manage various diseases are and are not at increased risk for SARS-CoV-2 infection, COVID-19 progression, and mortality.
As COVID-19 vaccine rollouts take place across the world, more questions have been raised about the relationship between B-cell depletion from anti-CD20 therapies and COVID-19 vaccines. Do rituximab and other anti-CD20 therapies affect a patient’s response to COVID-19 vaccines? If this is the case, does the timing of anti-CD20 treatment matter to maximize B-cell levels and improve the vaccine’s effectiveness? And how do COVID-19 vaccine booster doses factor into the equation?
Humoral and cell-mediated responses following COVID-19 vaccination
First, the bad news: The vaccine is unquestionably safe to administer in patients taking rituximab, but one thing that has been well established is that antibody response to COVID-19 vaccination in these individuals does is reduced. This isn’t entirely unprecedented, as previous studies have shown a weakened immune response to pneumococcal polysaccharide and keyhole limpet hemocyanin vaccines among patients taking rituximab.
“Compromised immunogenicity to the SARS-CoV-2 vaccines has been demonstrated in rituximab-treated patients, which is of particular concern given the observation that B-cell–depleting therapies may be associated with worse COVID outcomes,” Robert F. Spiera, MD, director of the Scleroderma, Vasculitis, and Myositis Center at the Hospital for Special Surgery in New York, said in an interview.
For example, in a recent study from the Medical University of Vienna, 29 (39%) of 74 patients receiving rituximab (43% as monotherapy, 57% with conventional-synthetic disease-modifying antirheumatic drugs) who were vaccinated with either the Comirnaty (Pfizer-BioNTech) or Spikevax (Moderna) COVID-19 vaccine achieved seroconversion, compared with 100% of patients in a healthy control group, and all but 1 patient without detectable CD19+ peripheral B cells did not develop anti–SARS-CoV-2 receptor-binding domain antibodies.
“There is an increasing number of studies in this field, and they confirm that patients treated with rituximab and other anti-CD20 agents have severely reduced serological responses to COVID-19 vaccines,” Ingrid Jyssum, MD, of the division of rheumatology and research at Diakonhjemmet Hospital in Oslo, said in an interview.
One silver lining is that patients treated with anti-CD20 therapies appear to have a cell-mediated response following vaccination even if they don’t develop SARS-CoV-2 antibodies. “Studies that also investigate T-cell responses are starting to emerge, and so far, they show that, even if the patients do not have antibodies, they may have T-cell responses,” Dr. Jyssum said.
One study of 24 patients with autoimmune diseases taking rituximab that evaluated humoral and T-cell responses following vaccination with the Comirnaty vaccine found that none had a humoral response to the vaccine, but the T-cell response from that group did not significantly differ from 35 patients receiving other immunosuppressants and 26 patients in a healthy control group. In another study of rituximab- or ocrelizumab-treated patients who received mRNA-based COVID-19 vaccines, 69.4% developed SARS-CoV-2–specific antibodies, compared with a control group, but 96.2% of patients taking ocrelizumab and 81.8% of patients taking rituximab mounted a spike-specific CD8+ T-cell response, compared with 66.7% in the control group, and there were comparable rates (85%-90%) of spike-specific CD4+ T cells in all groups. In the study from the Medical University of Vienna, T-cell response was detected in rituximab-treated patients who both did and did not mount an antibody response.
The clinical relevance of how a blunted humoral immune response but a respectable T-cell response to COVID-19 vaccines affects patients treated with anti-CD20 therapies isn’t currently known, Dr. Jyssum said.
While these data are reassuring, they’re also incomplete, Dr. Spiera noted. “The ultimate outcome of relevance to assess vaccine efficacy is protection from COVID and from severe outcomes of COVID infection (i.e., hospitalization, mechanical ventilation, death). That data will require assessment of very large numbers of rituximab-treated vaccinated patients to be compared with rituximab-treated unvaccinated patients, and is unlikely to be forthcoming in the very near future.
“In the meantime, however, achieving serologic positivity, meaning having evidence of serologic as well as cellular immunity following vaccination, is a desired outcome, and likely implies more robust immunity.”
Does treatment timing impact COVID-19 vaccine response?
Given enough time, B-cell reconstitution will occur in patients taking rituximab. With that in mind, is it beneficial to wait a certain amount of time after a patient has stopped rituximab therapy or time since their last dose before giving them a COVID-19 vaccine? In their guidance on COVID-19 vaccines for patients with rheumatic and musculoskeletal diseases, the American College of Rheumatology said there is moderate evidence to consider “optimal timing of dosing and vaccination with the rheumatology provider before proceeding.”
“Guidelines and preliminary studies of serologic response to COVID vaccine in rituximab-treated patients have suggested that longer time from last rituximab exposure is associated with a greater likelihood of a serologic response,” Dr. Spiera said.
In a brief report published in Arthritis & Rheumatology, Dr. Spiera and colleagues performed a retrospective chart review of 56 patients with varying levels of last exposure to rituximab who received a COVID-19 vaccine. Their results showed that, when patients were vaccinated 6-12 months after the last rituximab dose, 55% were seronegative, and when this was more than 12 months, only 13% were seronegative, compared with seronegativity in 86% who were vaccinated less than 6 months after their last rituximab dose.
The RituxiVac trial, conducted by researchers in Switzerland, also examined vaccine responses of 96 rituximab-treated patients who received Comirnaty or Spikevax; results recently published in The Lancet Rheumatology showed findings similar to other studies, with reduced humoral and cell-mediated responses. In the RituxiVac trial, the median time to last anti-CD20 treatment was 1.07 years.
“The typical interval between rituximab doses [for treatment of rheumatoid arthritis, as well as for remission maintenance in antineutrophil cytoplasmic antibody–associated vasculitis] is typically 6 months, and this has become widely used as the interval from last rituximab to time of COVID vaccination, with a recommendation to wait 4 weeks (if possible) from time of vaccination until the next rituximab administration,” Dr. Spiera explained. However, this window seems to vary depending on the study.
Recent research published in Arthritis & Rheumatology indicates B-cell levels could be a relevant indicator for humoral and cell-mediated response in patients with rheumatic diseases treated with rituximab, with a level of 10 B cells/mcL (0.4% of lymphocytes) identified as one potential marker for likely seroconversion following COVID-19 vaccination.
“In some smaller case series, it has been further recognized that rituximab-treated patients who were beginning to reconstitute peripheral B cells were most likely to respond serologically. Our present study confirmed those findings, demonstrating that the presence of detectable B cells was strongly associated with vaccine responsiveness, and affords complementary information to time from last [rituximab dose] in informing the likelihood of a vaccine response,” Dr. Spiera said.
However, the literature is limited in this area, and an exact cutoff for B-cell counts in these patients isn’t currently known, Dr. Jyssum said. A better metric is time away from anti-CD20 therapies, with CD19 cell count being highly correlated with last infusion.
Dr. Spiera agreed that there is no consistent B-cell percentage that works as a cutoff. “In our study, we looked at it as a binary variable, although we did find that a higher percentage of B cells in the peripheral lymphocyte population was associated with a higher likelihood of seroconversion. We did not, however, identify a ‘threshold’ for vaccine serologic responsiveness.”
Should clinicians measure antibodies?
The Food and Drug Administration and the Centers for Disease Control and Prevention have recommended that health care providers and the public not use COVID-19 antibody tests as a way to gauge immunity after exposure to SARS-CoV-2 and after receiving a COVID-19 vaccination. The ACR’s guidance on COVID-19 vaccination for patients with rheumatic and musculoskeletal diseases strongly recommends against ordering antibody tests for patients with autoimmune inflammatory rheumatic diseases as a way to measure immunity.
“Generally, such measurements are not recommended as the clinical correlate of various antibody levels are not known,” Dr. Jyssum said. “With regular infusions of rituximab or other anti-CD20 agents, one cannot expect that these patients will develop significant levels of antibodies.”
However, she said there might be situations where it’s useful to know whether a patient has developed antibodies at all. “Assessing the significance of specific antibody levels is difficult, and the subject of scientific studies. Patients lacking a humoral vaccine response are left to rely on their T-cell responses and on infectious control measures to prevent disease.”
Dr. Spiera said he disagreed with guidelines recommending against checking antibody levels after vaccination, “particularly in patients treated with immunosuppressive medications that might be expected to blunt their serologic response to the vaccines.
“Although we cannot be sure what level of measurable antibodies offer what level of protection, most clinicians would agree that patients who demonstrate no detectable antibodies (which is a common finding in rituximab-treated patients) should be considered at higher risk,” he said. “Indeed, recommendations regarding booster vaccine administration in general was initially based on the observation of declining antibody levels with longer time from vaccination.”
Do COVID-19 vaccine boosters help patients on anti-CD20 therapy?
As of January 2022, the FDA and CDC have recommended a third primary series shot of COVID-19 vaccines for some moderately to severely immunocompromised patients as young as 5 years old (for Comirnaty vaccine) or a booster shot of either Comirnaty or Spikevax for everyone aged 12 years and older, including immunocompromised people, while the ACR goes into more detail and recommends clinicians time a patient’s booster shot with temporary treatment interruption.
In The Lancet Rheumatology, Dr. Jyssum and colleagues recently published results from the prospective Nor-vaC study examining the humoral and cell-mediated immune responses of 87 patients with RA being treated with rituximab who received the Comirnaty, Spikevax, or Vaxzevria (AstraZeneca) COVID-19 vaccines; of these, 49 patients received a booster dose at a median of 70 days after completing their primary series. The results showed 19 patients (28.1%) had a serologic response after their primary series, while 8 of 49 patients (16.3%) who received their booster dose had a serologic response.
All patients who received a third dose in the study had a T-cell response, Dr. Jyssum said. “This is reassuring for patients and clinicians. T cells have been found to be important in countering COVID-19 disease, but whether we can rely on the T-cell response alone in the absence of antibodies to protect patients from infection or from serious COVID disease is still not determined,” she said.
When asked if she would recommend COVID-19 vaccine booster doses for patients on rituximab, Dr. Jyssum replied: “Absolutely.”
Another study, recently published in Annals of the Rheumatic Diseases, examined heterologous and homologous booster doses for 60 patients receiving rituximab without seroconversion after their COVID-19 vaccine primary series. The results showed no significant difference in new seroconversion at 4 weeks based on whether the patient received a vector or mRNA vaccine (22% vs. 32%), but all patients who received a booster dose with a vector vaccine had specific T-cell responses, compared with 81% of patients who received an mRNA vaccine booster. There was a new humoral and/or cellular response in 9 of 11 patients (82%), and most patients with peripheral B cells (12 of 18 patients; 67%) achieved seroconversion.
“Our data show that a cellular and/or humoral immune response can be achieved on a third COVID-19 vaccination in most of the patients who initially developed neither a humoral nor a cellular immune response,” the researchers concluded. “The efficacy data together with the safety data seen in our trial provide a favorable risk/benefit ratio and support the implementation of a third vaccination for nonseroconverted high-risk autoimmune disease patients treated with B-cell–depleting agents.”
Dr. Spiera said booster doses are an important part of the equation, and “it is important to consider factors that would be associated with a greater likelihood of achieving a serologic response, particularly in those patients who did not demonstrate a serologic response to the initial vaccines series.
“Preliminary data shows that the beginnings of B-cell reconstitution is also associated with a positive serologic response following a booster of the COVID-19 vaccine,” he said.
The authors of the cited studies reported numerous relevant financial disclosures. Dr. Spiera and Dr. Jyssum reported no relevant financial disclosures.
Rituximab has presented something of a conundrum for patients taking the monoclonal antibody during the COVID-19 pandemic.
Used to manage a variety of autoimmune diseases and cancers, rituximab acts against CD20 proteins expressed on the surface of B cells, causing B-cell depletion. However, it is this B-cell depletion that may put these patients at greater risk of COVID-19 development, progression to more severe disease, and in-hospital mortality. Evidence for this appears to be mixed, with studies showing both that patients using rituximab to manage various diseases are and are not at increased risk for SARS-CoV-2 infection, COVID-19 progression, and mortality.
As COVID-19 vaccine rollouts take place across the world, more questions have been raised about the relationship between B-cell depletion from anti-CD20 therapies and COVID-19 vaccines. Do rituximab and other anti-CD20 therapies affect a patient’s response to COVID-19 vaccines? If this is the case, does the timing of anti-CD20 treatment matter to maximize B-cell levels and improve the vaccine’s effectiveness? And how do COVID-19 vaccine booster doses factor into the equation?
Humoral and cell-mediated responses following COVID-19 vaccination
First, the bad news: The vaccine is unquestionably safe to administer in patients taking rituximab, but one thing that has been well established is that antibody response to COVID-19 vaccination in these individuals does is reduced. This isn’t entirely unprecedented, as previous studies have shown a weakened immune response to pneumococcal polysaccharide and keyhole limpet hemocyanin vaccines among patients taking rituximab.
“Compromised immunogenicity to the SARS-CoV-2 vaccines has been demonstrated in rituximab-treated patients, which is of particular concern given the observation that B-cell–depleting therapies may be associated with worse COVID outcomes,” Robert F. Spiera, MD, director of the Scleroderma, Vasculitis, and Myositis Center at the Hospital for Special Surgery in New York, said in an interview.
For example, in a recent study from the Medical University of Vienna, 29 (39%) of 74 patients receiving rituximab (43% as monotherapy, 57% with conventional-synthetic disease-modifying antirheumatic drugs) who were vaccinated with either the Comirnaty (Pfizer-BioNTech) or Spikevax (Moderna) COVID-19 vaccine achieved seroconversion, compared with 100% of patients in a healthy control group, and all but 1 patient without detectable CD19+ peripheral B cells did not develop anti–SARS-CoV-2 receptor-binding domain antibodies.
“There is an increasing number of studies in this field, and they confirm that patients treated with rituximab and other anti-CD20 agents have severely reduced serological responses to COVID-19 vaccines,” Ingrid Jyssum, MD, of the division of rheumatology and research at Diakonhjemmet Hospital in Oslo, said in an interview.
One silver lining is that patients treated with anti-CD20 therapies appear to have a cell-mediated response following vaccination even if they don’t develop SARS-CoV-2 antibodies. “Studies that also investigate T-cell responses are starting to emerge, and so far, they show that, even if the patients do not have antibodies, they may have T-cell responses,” Dr. Jyssum said.
One study of 24 patients with autoimmune diseases taking rituximab that evaluated humoral and T-cell responses following vaccination with the Comirnaty vaccine found that none had a humoral response to the vaccine, but the T-cell response from that group did not significantly differ from 35 patients receiving other immunosuppressants and 26 patients in a healthy control group. In another study of rituximab- or ocrelizumab-treated patients who received mRNA-based COVID-19 vaccines, 69.4% developed SARS-CoV-2–specific antibodies, compared with a control group, but 96.2% of patients taking ocrelizumab and 81.8% of patients taking rituximab mounted a spike-specific CD8+ T-cell response, compared with 66.7% in the control group, and there were comparable rates (85%-90%) of spike-specific CD4+ T cells in all groups. In the study from the Medical University of Vienna, T-cell response was detected in rituximab-treated patients who both did and did not mount an antibody response.
The clinical relevance of how a blunted humoral immune response but a respectable T-cell response to COVID-19 vaccines affects patients treated with anti-CD20 therapies isn’t currently known, Dr. Jyssum said.
While these data are reassuring, they’re also incomplete, Dr. Spiera noted. “The ultimate outcome of relevance to assess vaccine efficacy is protection from COVID and from severe outcomes of COVID infection (i.e., hospitalization, mechanical ventilation, death). That data will require assessment of very large numbers of rituximab-treated vaccinated patients to be compared with rituximab-treated unvaccinated patients, and is unlikely to be forthcoming in the very near future.
“In the meantime, however, achieving serologic positivity, meaning having evidence of serologic as well as cellular immunity following vaccination, is a desired outcome, and likely implies more robust immunity.”
Does treatment timing impact COVID-19 vaccine response?
Given enough time, B-cell reconstitution will occur in patients taking rituximab. With that in mind, is it beneficial to wait a certain amount of time after a patient has stopped rituximab therapy or time since their last dose before giving them a COVID-19 vaccine? In their guidance on COVID-19 vaccines for patients with rheumatic and musculoskeletal diseases, the American College of Rheumatology said there is moderate evidence to consider “optimal timing of dosing and vaccination with the rheumatology provider before proceeding.”
“Guidelines and preliminary studies of serologic response to COVID vaccine in rituximab-treated patients have suggested that longer time from last rituximab exposure is associated with a greater likelihood of a serologic response,” Dr. Spiera said.
In a brief report published in Arthritis & Rheumatology, Dr. Spiera and colleagues performed a retrospective chart review of 56 patients with varying levels of last exposure to rituximab who received a COVID-19 vaccine. Their results showed that, when patients were vaccinated 6-12 months after the last rituximab dose, 55% were seronegative, and when this was more than 12 months, only 13% were seronegative, compared with seronegativity in 86% who were vaccinated less than 6 months after their last rituximab dose.
The RituxiVac trial, conducted by researchers in Switzerland, also examined vaccine responses of 96 rituximab-treated patients who received Comirnaty or Spikevax; results recently published in The Lancet Rheumatology showed findings similar to other studies, with reduced humoral and cell-mediated responses. In the RituxiVac trial, the median time to last anti-CD20 treatment was 1.07 years.
“The typical interval between rituximab doses [for treatment of rheumatoid arthritis, as well as for remission maintenance in antineutrophil cytoplasmic antibody–associated vasculitis] is typically 6 months, and this has become widely used as the interval from last rituximab to time of COVID vaccination, with a recommendation to wait 4 weeks (if possible) from time of vaccination until the next rituximab administration,” Dr. Spiera explained. However, this window seems to vary depending on the study.
Recent research published in Arthritis & Rheumatology indicates B-cell levels could be a relevant indicator for humoral and cell-mediated response in patients with rheumatic diseases treated with rituximab, with a level of 10 B cells/mcL (0.4% of lymphocytes) identified as one potential marker for likely seroconversion following COVID-19 vaccination.
“In some smaller case series, it has been further recognized that rituximab-treated patients who were beginning to reconstitute peripheral B cells were most likely to respond serologically. Our present study confirmed those findings, demonstrating that the presence of detectable B cells was strongly associated with vaccine responsiveness, and affords complementary information to time from last [rituximab dose] in informing the likelihood of a vaccine response,” Dr. Spiera said.
However, the literature is limited in this area, and an exact cutoff for B-cell counts in these patients isn’t currently known, Dr. Jyssum said. A better metric is time away from anti-CD20 therapies, with CD19 cell count being highly correlated with last infusion.
Dr. Spiera agreed that there is no consistent B-cell percentage that works as a cutoff. “In our study, we looked at it as a binary variable, although we did find that a higher percentage of B cells in the peripheral lymphocyte population was associated with a higher likelihood of seroconversion. We did not, however, identify a ‘threshold’ for vaccine serologic responsiveness.”
Should clinicians measure antibodies?
The Food and Drug Administration and the Centers for Disease Control and Prevention have recommended that health care providers and the public not use COVID-19 antibody tests as a way to gauge immunity after exposure to SARS-CoV-2 and after receiving a COVID-19 vaccination. The ACR’s guidance on COVID-19 vaccination for patients with rheumatic and musculoskeletal diseases strongly recommends against ordering antibody tests for patients with autoimmune inflammatory rheumatic diseases as a way to measure immunity.
“Generally, such measurements are not recommended as the clinical correlate of various antibody levels are not known,” Dr. Jyssum said. “With regular infusions of rituximab or other anti-CD20 agents, one cannot expect that these patients will develop significant levels of antibodies.”
However, she said there might be situations where it’s useful to know whether a patient has developed antibodies at all. “Assessing the significance of specific antibody levels is difficult, and the subject of scientific studies. Patients lacking a humoral vaccine response are left to rely on their T-cell responses and on infectious control measures to prevent disease.”
Dr. Spiera said he disagreed with guidelines recommending against checking antibody levels after vaccination, “particularly in patients treated with immunosuppressive medications that might be expected to blunt their serologic response to the vaccines.
“Although we cannot be sure what level of measurable antibodies offer what level of protection, most clinicians would agree that patients who demonstrate no detectable antibodies (which is a common finding in rituximab-treated patients) should be considered at higher risk,” he said. “Indeed, recommendations regarding booster vaccine administration in general was initially based on the observation of declining antibody levels with longer time from vaccination.”
Do COVID-19 vaccine boosters help patients on anti-CD20 therapy?
As of January 2022, the FDA and CDC have recommended a third primary series shot of COVID-19 vaccines for some moderately to severely immunocompromised patients as young as 5 years old (for Comirnaty vaccine) or a booster shot of either Comirnaty or Spikevax for everyone aged 12 years and older, including immunocompromised people, while the ACR goes into more detail and recommends clinicians time a patient’s booster shot with temporary treatment interruption.
In The Lancet Rheumatology, Dr. Jyssum and colleagues recently published results from the prospective Nor-vaC study examining the humoral and cell-mediated immune responses of 87 patients with RA being treated with rituximab who received the Comirnaty, Spikevax, or Vaxzevria (AstraZeneca) COVID-19 vaccines; of these, 49 patients received a booster dose at a median of 70 days after completing their primary series. The results showed 19 patients (28.1%) had a serologic response after their primary series, while 8 of 49 patients (16.3%) who received their booster dose had a serologic response.
All patients who received a third dose in the study had a T-cell response, Dr. Jyssum said. “This is reassuring for patients and clinicians. T cells have been found to be important in countering COVID-19 disease, but whether we can rely on the T-cell response alone in the absence of antibodies to protect patients from infection or from serious COVID disease is still not determined,” she said.
When asked if she would recommend COVID-19 vaccine booster doses for patients on rituximab, Dr. Jyssum replied: “Absolutely.”
Another study, recently published in Annals of the Rheumatic Diseases, examined heterologous and homologous booster doses for 60 patients receiving rituximab without seroconversion after their COVID-19 vaccine primary series. The results showed no significant difference in new seroconversion at 4 weeks based on whether the patient received a vector or mRNA vaccine (22% vs. 32%), but all patients who received a booster dose with a vector vaccine had specific T-cell responses, compared with 81% of patients who received an mRNA vaccine booster. There was a new humoral and/or cellular response in 9 of 11 patients (82%), and most patients with peripheral B cells (12 of 18 patients; 67%) achieved seroconversion.
“Our data show that a cellular and/or humoral immune response can be achieved on a third COVID-19 vaccination in most of the patients who initially developed neither a humoral nor a cellular immune response,” the researchers concluded. “The efficacy data together with the safety data seen in our trial provide a favorable risk/benefit ratio and support the implementation of a third vaccination for nonseroconverted high-risk autoimmune disease patients treated with B-cell–depleting agents.”
Dr. Spiera said booster doses are an important part of the equation, and “it is important to consider factors that would be associated with a greater likelihood of achieving a serologic response, particularly in those patients who did not demonstrate a serologic response to the initial vaccines series.
“Preliminary data shows that the beginnings of B-cell reconstitution is also associated with a positive serologic response following a booster of the COVID-19 vaccine,” he said.
The authors of the cited studies reported numerous relevant financial disclosures. Dr. Spiera and Dr. Jyssum reported no relevant financial disclosures.
Rituximab has presented something of a conundrum for patients taking the monoclonal antibody during the COVID-19 pandemic.
Used to manage a variety of autoimmune diseases and cancers, rituximab acts against CD20 proteins expressed on the surface of B cells, causing B-cell depletion. However, it is this B-cell depletion that may put these patients at greater risk of COVID-19 development, progression to more severe disease, and in-hospital mortality. Evidence for this appears to be mixed, with studies showing both that patients using rituximab to manage various diseases are and are not at increased risk for SARS-CoV-2 infection, COVID-19 progression, and mortality.
As COVID-19 vaccine rollouts take place across the world, more questions have been raised about the relationship between B-cell depletion from anti-CD20 therapies and COVID-19 vaccines. Do rituximab and other anti-CD20 therapies affect a patient’s response to COVID-19 vaccines? If this is the case, does the timing of anti-CD20 treatment matter to maximize B-cell levels and improve the vaccine’s effectiveness? And how do COVID-19 vaccine booster doses factor into the equation?
Humoral and cell-mediated responses following COVID-19 vaccination
First, the bad news: The vaccine is unquestionably safe to administer in patients taking rituximab, but one thing that has been well established is that antibody response to COVID-19 vaccination in these individuals does is reduced. This isn’t entirely unprecedented, as previous studies have shown a weakened immune response to pneumococcal polysaccharide and keyhole limpet hemocyanin vaccines among patients taking rituximab.
“Compromised immunogenicity to the SARS-CoV-2 vaccines has been demonstrated in rituximab-treated patients, which is of particular concern given the observation that B-cell–depleting therapies may be associated with worse COVID outcomes,” Robert F. Spiera, MD, director of the Scleroderma, Vasculitis, and Myositis Center at the Hospital for Special Surgery in New York, said in an interview.
For example, in a recent study from the Medical University of Vienna, 29 (39%) of 74 patients receiving rituximab (43% as monotherapy, 57% with conventional-synthetic disease-modifying antirheumatic drugs) who were vaccinated with either the Comirnaty (Pfizer-BioNTech) or Spikevax (Moderna) COVID-19 vaccine achieved seroconversion, compared with 100% of patients in a healthy control group, and all but 1 patient without detectable CD19+ peripheral B cells did not develop anti–SARS-CoV-2 receptor-binding domain antibodies.
“There is an increasing number of studies in this field, and they confirm that patients treated with rituximab and other anti-CD20 agents have severely reduced serological responses to COVID-19 vaccines,” Ingrid Jyssum, MD, of the division of rheumatology and research at Diakonhjemmet Hospital in Oslo, said in an interview.
One silver lining is that patients treated with anti-CD20 therapies appear to have a cell-mediated response following vaccination even if they don’t develop SARS-CoV-2 antibodies. “Studies that also investigate T-cell responses are starting to emerge, and so far, they show that, even if the patients do not have antibodies, they may have T-cell responses,” Dr. Jyssum said.
One study of 24 patients with autoimmune diseases taking rituximab that evaluated humoral and T-cell responses following vaccination with the Comirnaty vaccine found that none had a humoral response to the vaccine, but the T-cell response from that group did not significantly differ from 35 patients receiving other immunosuppressants and 26 patients in a healthy control group. In another study of rituximab- or ocrelizumab-treated patients who received mRNA-based COVID-19 vaccines, 69.4% developed SARS-CoV-2–specific antibodies, compared with a control group, but 96.2% of patients taking ocrelizumab and 81.8% of patients taking rituximab mounted a spike-specific CD8+ T-cell response, compared with 66.7% in the control group, and there were comparable rates (85%-90%) of spike-specific CD4+ T cells in all groups. In the study from the Medical University of Vienna, T-cell response was detected in rituximab-treated patients who both did and did not mount an antibody response.
The clinical relevance of how a blunted humoral immune response but a respectable T-cell response to COVID-19 vaccines affects patients treated with anti-CD20 therapies isn’t currently known, Dr. Jyssum said.
While these data are reassuring, they’re also incomplete, Dr. Spiera noted. “The ultimate outcome of relevance to assess vaccine efficacy is protection from COVID and from severe outcomes of COVID infection (i.e., hospitalization, mechanical ventilation, death). That data will require assessment of very large numbers of rituximab-treated vaccinated patients to be compared with rituximab-treated unvaccinated patients, and is unlikely to be forthcoming in the very near future.
“In the meantime, however, achieving serologic positivity, meaning having evidence of serologic as well as cellular immunity following vaccination, is a desired outcome, and likely implies more robust immunity.”
Does treatment timing impact COVID-19 vaccine response?
Given enough time, B-cell reconstitution will occur in patients taking rituximab. With that in mind, is it beneficial to wait a certain amount of time after a patient has stopped rituximab therapy or time since their last dose before giving them a COVID-19 vaccine? In their guidance on COVID-19 vaccines for patients with rheumatic and musculoskeletal diseases, the American College of Rheumatology said there is moderate evidence to consider “optimal timing of dosing and vaccination with the rheumatology provider before proceeding.”
“Guidelines and preliminary studies of serologic response to COVID vaccine in rituximab-treated patients have suggested that longer time from last rituximab exposure is associated with a greater likelihood of a serologic response,” Dr. Spiera said.
In a brief report published in Arthritis & Rheumatology, Dr. Spiera and colleagues performed a retrospective chart review of 56 patients with varying levels of last exposure to rituximab who received a COVID-19 vaccine. Their results showed that, when patients were vaccinated 6-12 months after the last rituximab dose, 55% were seronegative, and when this was more than 12 months, only 13% were seronegative, compared with seronegativity in 86% who were vaccinated less than 6 months after their last rituximab dose.
The RituxiVac trial, conducted by researchers in Switzerland, also examined vaccine responses of 96 rituximab-treated patients who received Comirnaty or Spikevax; results recently published in The Lancet Rheumatology showed findings similar to other studies, with reduced humoral and cell-mediated responses. In the RituxiVac trial, the median time to last anti-CD20 treatment was 1.07 years.
“The typical interval between rituximab doses [for treatment of rheumatoid arthritis, as well as for remission maintenance in antineutrophil cytoplasmic antibody–associated vasculitis] is typically 6 months, and this has become widely used as the interval from last rituximab to time of COVID vaccination, with a recommendation to wait 4 weeks (if possible) from time of vaccination until the next rituximab administration,” Dr. Spiera explained. However, this window seems to vary depending on the study.
Recent research published in Arthritis & Rheumatology indicates B-cell levels could be a relevant indicator for humoral and cell-mediated response in patients with rheumatic diseases treated with rituximab, with a level of 10 B cells/mcL (0.4% of lymphocytes) identified as one potential marker for likely seroconversion following COVID-19 vaccination.
“In some smaller case series, it has been further recognized that rituximab-treated patients who were beginning to reconstitute peripheral B cells were most likely to respond serologically. Our present study confirmed those findings, demonstrating that the presence of detectable B cells was strongly associated with vaccine responsiveness, and affords complementary information to time from last [rituximab dose] in informing the likelihood of a vaccine response,” Dr. Spiera said.
However, the literature is limited in this area, and an exact cutoff for B-cell counts in these patients isn’t currently known, Dr. Jyssum said. A better metric is time away from anti-CD20 therapies, with CD19 cell count being highly correlated with last infusion.
Dr. Spiera agreed that there is no consistent B-cell percentage that works as a cutoff. “In our study, we looked at it as a binary variable, although we did find that a higher percentage of B cells in the peripheral lymphocyte population was associated with a higher likelihood of seroconversion. We did not, however, identify a ‘threshold’ for vaccine serologic responsiveness.”
Should clinicians measure antibodies?
The Food and Drug Administration and the Centers for Disease Control and Prevention have recommended that health care providers and the public not use COVID-19 antibody tests as a way to gauge immunity after exposure to SARS-CoV-2 and after receiving a COVID-19 vaccination. The ACR’s guidance on COVID-19 vaccination for patients with rheumatic and musculoskeletal diseases strongly recommends against ordering antibody tests for patients with autoimmune inflammatory rheumatic diseases as a way to measure immunity.
“Generally, such measurements are not recommended as the clinical correlate of various antibody levels are not known,” Dr. Jyssum said. “With regular infusions of rituximab or other anti-CD20 agents, one cannot expect that these patients will develop significant levels of antibodies.”
However, she said there might be situations where it’s useful to know whether a patient has developed antibodies at all. “Assessing the significance of specific antibody levels is difficult, and the subject of scientific studies. Patients lacking a humoral vaccine response are left to rely on their T-cell responses and on infectious control measures to prevent disease.”
Dr. Spiera said he disagreed with guidelines recommending against checking antibody levels after vaccination, “particularly in patients treated with immunosuppressive medications that might be expected to blunt their serologic response to the vaccines.
“Although we cannot be sure what level of measurable antibodies offer what level of protection, most clinicians would agree that patients who demonstrate no detectable antibodies (which is a common finding in rituximab-treated patients) should be considered at higher risk,” he said. “Indeed, recommendations regarding booster vaccine administration in general was initially based on the observation of declining antibody levels with longer time from vaccination.”
Do COVID-19 vaccine boosters help patients on anti-CD20 therapy?
As of January 2022, the FDA and CDC have recommended a third primary series shot of COVID-19 vaccines for some moderately to severely immunocompromised patients as young as 5 years old (for Comirnaty vaccine) or a booster shot of either Comirnaty or Spikevax for everyone aged 12 years and older, including immunocompromised people, while the ACR goes into more detail and recommends clinicians time a patient’s booster shot with temporary treatment interruption.
In The Lancet Rheumatology, Dr. Jyssum and colleagues recently published results from the prospective Nor-vaC study examining the humoral and cell-mediated immune responses of 87 patients with RA being treated with rituximab who received the Comirnaty, Spikevax, or Vaxzevria (AstraZeneca) COVID-19 vaccines; of these, 49 patients received a booster dose at a median of 70 days after completing their primary series. The results showed 19 patients (28.1%) had a serologic response after their primary series, while 8 of 49 patients (16.3%) who received their booster dose had a serologic response.
All patients who received a third dose in the study had a T-cell response, Dr. Jyssum said. “This is reassuring for patients and clinicians. T cells have been found to be important in countering COVID-19 disease, but whether we can rely on the T-cell response alone in the absence of antibodies to protect patients from infection or from serious COVID disease is still not determined,” she said.
When asked if she would recommend COVID-19 vaccine booster doses for patients on rituximab, Dr. Jyssum replied: “Absolutely.”
Another study, recently published in Annals of the Rheumatic Diseases, examined heterologous and homologous booster doses for 60 patients receiving rituximab without seroconversion after their COVID-19 vaccine primary series. The results showed no significant difference in new seroconversion at 4 weeks based on whether the patient received a vector or mRNA vaccine (22% vs. 32%), but all patients who received a booster dose with a vector vaccine had specific T-cell responses, compared with 81% of patients who received an mRNA vaccine booster. There was a new humoral and/or cellular response in 9 of 11 patients (82%), and most patients with peripheral B cells (12 of 18 patients; 67%) achieved seroconversion.
“Our data show that a cellular and/or humoral immune response can be achieved on a third COVID-19 vaccination in most of the patients who initially developed neither a humoral nor a cellular immune response,” the researchers concluded. “The efficacy data together with the safety data seen in our trial provide a favorable risk/benefit ratio and support the implementation of a third vaccination for nonseroconverted high-risk autoimmune disease patients treated with B-cell–depleting agents.”
Dr. Spiera said booster doses are an important part of the equation, and “it is important to consider factors that would be associated with a greater likelihood of achieving a serologic response, particularly in those patients who did not demonstrate a serologic response to the initial vaccines series.
“Preliminary data shows that the beginnings of B-cell reconstitution is also associated with a positive serologic response following a booster of the COVID-19 vaccine,” he said.
The authors of the cited studies reported numerous relevant financial disclosures. Dr. Spiera and Dr. Jyssum reported no relevant financial disclosures.
Fourth vaccine shot less effective against Omicron, Israeli study says
, according to new research at an Israeli hospital.
The preliminary results, released on Jan. 17, challenge the idea of giving a second booster dose to slow the spread of the coronavirus, according to USA Today.
“Despite increased antibody levels, the fourth vaccine only offers a partial defense against the virus,” Gili Regev-Yochay, MD, director of the hospital’s infection prevention and control units, told reporters.
“The vaccines, which were more effective against previous variants, offer less protection versus Omicron,” she said.
In a clinical trial, 274 medical workers at Sheba Medical Center near Tel Aviv received a fourth vaccine dose in December – 154 got the Pfizer vaccine and 120 got the Moderna vaccine – after previously getting three Pfizer shots.
Both groups received a boost in antibodies that was “slightly higher” than after the third shot, Dr. Regev-Yochay said. But when compared with a control group that didn’t receive the fourth dose, the extra boost didn’t prevent the spread of Omicron.
“We see many infected with Omicron who received the fourth dose,” Dr. Regev-Yochay said. “Granted, a bit less than in the control group, but still a lot of infections.”
Some public health officials in Israel say the campaign for fourth doses is still worthwhile, according to The Times of Israel. The vaccine still works well against the Alpha and Delta variants, Dr. Regev-Yochay said, and a fourth shot should go to older adults and those who face higher risks for severe COVID-19.
Hours after releasing the preliminary results, Sheba Medical Center published a statement calling for “continuing the vaccination drive for risk groups at this time, even though the vaccine doesn’t provide optimal protection against getting infected with the variant.” News outlets reported that the hospital was pressured into issuing the statement after Israel’s Health Ministry didn’t like the release of the early study results, The Times of Israel reported.
The second booster “returns the level of antibodies to what it was at the beginning of the third booster,” Nachman Ash, MD, director of Israel’s Health Ministry, told Channel 13 TV in Israel, according to The Associated Press.
“That has great importance, especially among the older population,” he said.
As of Sunday, more than 500,000 people in Israel had received fourth doses since the country began offering them last month to medical workers, immunocompromised patients, and people ages 60 years and older, the AP reported. At the same time, the country has faced a recent coronavirus surge that has led to record-breaking numbers of cases and rising hospitalizations.
On Tuesday, the Israeli government said it would shorten the mandatory quarantine period from 7 days to 5 days, the AP reported.
“This decision will enable us to continue safeguarding public health on the one hand and to keep the economy going at this time on the other, even though it is difficult, so that we can get through this wave safely,” Prime Minister Naftali Bennett said.
A version of this article first appeared on WebMD.com.
, according to new research at an Israeli hospital.
The preliminary results, released on Jan. 17, challenge the idea of giving a second booster dose to slow the spread of the coronavirus, according to USA Today.
“Despite increased antibody levels, the fourth vaccine only offers a partial defense against the virus,” Gili Regev-Yochay, MD, director of the hospital’s infection prevention and control units, told reporters.
“The vaccines, which were more effective against previous variants, offer less protection versus Omicron,” she said.
In a clinical trial, 274 medical workers at Sheba Medical Center near Tel Aviv received a fourth vaccine dose in December – 154 got the Pfizer vaccine and 120 got the Moderna vaccine – after previously getting three Pfizer shots.
Both groups received a boost in antibodies that was “slightly higher” than after the third shot, Dr. Regev-Yochay said. But when compared with a control group that didn’t receive the fourth dose, the extra boost didn’t prevent the spread of Omicron.
“We see many infected with Omicron who received the fourth dose,” Dr. Regev-Yochay said. “Granted, a bit less than in the control group, but still a lot of infections.”
Some public health officials in Israel say the campaign for fourth doses is still worthwhile, according to The Times of Israel. The vaccine still works well against the Alpha and Delta variants, Dr. Regev-Yochay said, and a fourth shot should go to older adults and those who face higher risks for severe COVID-19.
Hours after releasing the preliminary results, Sheba Medical Center published a statement calling for “continuing the vaccination drive for risk groups at this time, even though the vaccine doesn’t provide optimal protection against getting infected with the variant.” News outlets reported that the hospital was pressured into issuing the statement after Israel’s Health Ministry didn’t like the release of the early study results, The Times of Israel reported.
The second booster “returns the level of antibodies to what it was at the beginning of the third booster,” Nachman Ash, MD, director of Israel’s Health Ministry, told Channel 13 TV in Israel, according to The Associated Press.
“That has great importance, especially among the older population,” he said.
As of Sunday, more than 500,000 people in Israel had received fourth doses since the country began offering them last month to medical workers, immunocompromised patients, and people ages 60 years and older, the AP reported. At the same time, the country has faced a recent coronavirus surge that has led to record-breaking numbers of cases and rising hospitalizations.
On Tuesday, the Israeli government said it would shorten the mandatory quarantine period from 7 days to 5 days, the AP reported.
“This decision will enable us to continue safeguarding public health on the one hand and to keep the economy going at this time on the other, even though it is difficult, so that we can get through this wave safely,” Prime Minister Naftali Bennett said.
A version of this article first appeared on WebMD.com.
, according to new research at an Israeli hospital.
The preliminary results, released on Jan. 17, challenge the idea of giving a second booster dose to slow the spread of the coronavirus, according to USA Today.
“Despite increased antibody levels, the fourth vaccine only offers a partial defense against the virus,” Gili Regev-Yochay, MD, director of the hospital’s infection prevention and control units, told reporters.
“The vaccines, which were more effective against previous variants, offer less protection versus Omicron,” she said.
In a clinical trial, 274 medical workers at Sheba Medical Center near Tel Aviv received a fourth vaccine dose in December – 154 got the Pfizer vaccine and 120 got the Moderna vaccine – after previously getting three Pfizer shots.
Both groups received a boost in antibodies that was “slightly higher” than after the third shot, Dr. Regev-Yochay said. But when compared with a control group that didn’t receive the fourth dose, the extra boost didn’t prevent the spread of Omicron.
“We see many infected with Omicron who received the fourth dose,” Dr. Regev-Yochay said. “Granted, a bit less than in the control group, but still a lot of infections.”
Some public health officials in Israel say the campaign for fourth doses is still worthwhile, according to The Times of Israel. The vaccine still works well against the Alpha and Delta variants, Dr. Regev-Yochay said, and a fourth shot should go to older adults and those who face higher risks for severe COVID-19.
Hours after releasing the preliminary results, Sheba Medical Center published a statement calling for “continuing the vaccination drive for risk groups at this time, even though the vaccine doesn’t provide optimal protection against getting infected with the variant.” News outlets reported that the hospital was pressured into issuing the statement after Israel’s Health Ministry didn’t like the release of the early study results, The Times of Israel reported.
The second booster “returns the level of antibodies to what it was at the beginning of the third booster,” Nachman Ash, MD, director of Israel’s Health Ministry, told Channel 13 TV in Israel, according to The Associated Press.
“That has great importance, especially among the older population,” he said.
As of Sunday, more than 500,000 people in Israel had received fourth doses since the country began offering them last month to medical workers, immunocompromised patients, and people ages 60 years and older, the AP reported. At the same time, the country has faced a recent coronavirus surge that has led to record-breaking numbers of cases and rising hospitalizations.
On Tuesday, the Israeli government said it would shorten the mandatory quarantine period from 7 days to 5 days, the AP reported.
“This decision will enable us to continue safeguarding public health on the one hand and to keep the economy going at this time on the other, even though it is difficult, so that we can get through this wave safely,” Prime Minister Naftali Bennett said.
A version of this article first appeared on WebMD.com.
ACIP releases new dengue vaccine recommendations
The vaccine is only to be used for children aged 9-16 who live in endemic areas and who have evidence with a specific diagnostic test of prior dengue infection.
Dengue is a mosquito-borne virus found throughout the world, primarily in tropical or subtropical climates. Cases had steadily been increasing to 5.2 million in 2019, and the geographic distribution of cases is broadening with climate change and urbanization. About half of the world’s population is now at risk.
The dengue virus has four serotypes. The first infection may be mild or asymptomatic, but the second one can be life-threatening because of a phenomenon called antibody-dependent enhancement.
The lead author of the new recommendations is Gabriela Paz-Bailey, MD, PhD, division of vector-borne diseases, dengue branch, CDC. She told this news organization that, during the second infection, when there are “low levels of antibodies from that first infection, the antibodies help the virus get inside the cells. There the virus is not killed, and that results in increased viral load, and then that can result in more severe disease and the plasma leakage” syndrome, which can lead to shock, severe bleeding, and organ failure. The death rate for severe dengue is up to 13%.
Previous infection with Zika virus, common in the same areas where dengue is endemic, can also increase the risk for symptomatic and severe dengue for subsequent infections.
In the United States, Puerto Rico is the main focus of control efforts because 95% of domestic dengue cases originate there – almost 30,000 cases between 2010 and 2020, with 11,000 cases and 4,000 hospitalizations occurring in children between the ages of 10 and 19.
Because Aedes aegypti, the primary mosquito vector transmitting dengue, is resistant to all commonly used insecticides in Puerto Rico, preventive efforts have shifted from insecticides to vaccination.
Antibody tests prevaccination
The main concern with the Sanofi’s dengue vaccine is that it could act as an asymptomatic primary dengue infection, in effect priming the body for a severe reaction from antibody-dependent enhancement with a subsequent infection. That is why it’s critical that the vaccine only be given to children with evidence of prior disease.
Dr. Paz-Bailey said: “The CDC came up with recommendations of what the performance of the test used for prevaccination screening should be. And it was 98% specificity and 75% sensitivity. ... But no test by itself was found to have a specificity of 98%, and this is why we’re recommending the two-test algorithm,” in which two different assays are run off the same blood sample, drawn at a prevaccination visit.
If the child has evidence of prior dengue, they can proceed with vaccination to protect against recurrent infection. Dengvaxia is given as a series of three shots over 6 months. Vaccine efficacy is 82% – so not everyone is protected, and additionally, that protection declines over time.
There is concern that it will be difficult to achieve compliance with such a complex regimen. Dr. Paz-Bailey said, “But I think that the trust in vaccines that is highly prevalent for [Puerto] Rico and trusting the health care system, and sort of the importance that is assigned to dengue by providers and by parents because of previous outbreaks and previous experiences is going to help us.” She added, “I think that the COVID experience has been very revealing. And what we have learned is that Puerto Rico has a very strong health care system, a very strong network of vaccine providers. ... Coverage for COVID vaccine is higher than in other parts of the U.S.”
One of the interesting things about dengue is that the first infection can range from asymptomatic to life-threatening. The second infection is generally worse because of this antibody-dependent enhancement phenomenon. Eng Eong Ooi, MD, PhD, professor of microbiology and immunology, National University of Singapore, told this news organization, “After you have two infections, you seem to be protected quite well against the remaining two [serotypes]. The vaccine serves as another episode of infection in those who had prior dengue, so then any natural infections after the vaccination in the seropositive become like the outcome of a third or fourth infection.”
Vaccination alone will not solve dengue. Dr. Ooi said, “There’s not one method that would fully control dengue. You need both vaccines as well as control measures, whether it’s Wolbachia or something else. At the same time, I think we need antiviral drugs, because hitting this virus in just one part of its life cycle wouldn’t make a huge, lasting impact.” Dr. Ooi added that as “the spread of the virus and the population immunity drops, you’re actually now more vulnerable to dengue outbreaks when they do get introduced. So, suppressing transmission alone isn’t the answer. You also have to keep herd immunity levels high. So if we can reduce the virus transmission by controlling either mosquito population or transmission and at the same time vaccinate to keep the immunity levels high, then I think we have a chance of controlling dengue.”
Dr. Paz-Bailey concluded: “I do want to emphasize that we are excited about having these tools, because for years and years, we have had really limited options to prevent and control dengue. It’s an important addition to have the vaccine be approved to be used within the U.S., and it’s going to pave the road for future vaccines.”
Dr. Paz-Bailey and Dr. Ooi reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The vaccine is only to be used for children aged 9-16 who live in endemic areas and who have evidence with a specific diagnostic test of prior dengue infection.
Dengue is a mosquito-borne virus found throughout the world, primarily in tropical or subtropical climates. Cases had steadily been increasing to 5.2 million in 2019, and the geographic distribution of cases is broadening with climate change and urbanization. About half of the world’s population is now at risk.
The dengue virus has four serotypes. The first infection may be mild or asymptomatic, but the second one can be life-threatening because of a phenomenon called antibody-dependent enhancement.
The lead author of the new recommendations is Gabriela Paz-Bailey, MD, PhD, division of vector-borne diseases, dengue branch, CDC. She told this news organization that, during the second infection, when there are “low levels of antibodies from that first infection, the antibodies help the virus get inside the cells. There the virus is not killed, and that results in increased viral load, and then that can result in more severe disease and the plasma leakage” syndrome, which can lead to shock, severe bleeding, and organ failure. The death rate for severe dengue is up to 13%.
Previous infection with Zika virus, common in the same areas where dengue is endemic, can also increase the risk for symptomatic and severe dengue for subsequent infections.
In the United States, Puerto Rico is the main focus of control efforts because 95% of domestic dengue cases originate there – almost 30,000 cases between 2010 and 2020, with 11,000 cases and 4,000 hospitalizations occurring in children between the ages of 10 and 19.
Because Aedes aegypti, the primary mosquito vector transmitting dengue, is resistant to all commonly used insecticides in Puerto Rico, preventive efforts have shifted from insecticides to vaccination.
Antibody tests prevaccination
The main concern with the Sanofi’s dengue vaccine is that it could act as an asymptomatic primary dengue infection, in effect priming the body for a severe reaction from antibody-dependent enhancement with a subsequent infection. That is why it’s critical that the vaccine only be given to children with evidence of prior disease.
Dr. Paz-Bailey said: “The CDC came up with recommendations of what the performance of the test used for prevaccination screening should be. And it was 98% specificity and 75% sensitivity. ... But no test by itself was found to have a specificity of 98%, and this is why we’re recommending the two-test algorithm,” in which two different assays are run off the same blood sample, drawn at a prevaccination visit.
If the child has evidence of prior dengue, they can proceed with vaccination to protect against recurrent infection. Dengvaxia is given as a series of three shots over 6 months. Vaccine efficacy is 82% – so not everyone is protected, and additionally, that protection declines over time.
There is concern that it will be difficult to achieve compliance with such a complex regimen. Dr. Paz-Bailey said, “But I think that the trust in vaccines that is highly prevalent for [Puerto] Rico and trusting the health care system, and sort of the importance that is assigned to dengue by providers and by parents because of previous outbreaks and previous experiences is going to help us.” She added, “I think that the COVID experience has been very revealing. And what we have learned is that Puerto Rico has a very strong health care system, a very strong network of vaccine providers. ... Coverage for COVID vaccine is higher than in other parts of the U.S.”
One of the interesting things about dengue is that the first infection can range from asymptomatic to life-threatening. The second infection is generally worse because of this antibody-dependent enhancement phenomenon. Eng Eong Ooi, MD, PhD, professor of microbiology and immunology, National University of Singapore, told this news organization, “After you have two infections, you seem to be protected quite well against the remaining two [serotypes]. The vaccine serves as another episode of infection in those who had prior dengue, so then any natural infections after the vaccination in the seropositive become like the outcome of a third or fourth infection.”
Vaccination alone will not solve dengue. Dr. Ooi said, “There’s not one method that would fully control dengue. You need both vaccines as well as control measures, whether it’s Wolbachia or something else. At the same time, I think we need antiviral drugs, because hitting this virus in just one part of its life cycle wouldn’t make a huge, lasting impact.” Dr. Ooi added that as “the spread of the virus and the population immunity drops, you’re actually now more vulnerable to dengue outbreaks when they do get introduced. So, suppressing transmission alone isn’t the answer. You also have to keep herd immunity levels high. So if we can reduce the virus transmission by controlling either mosquito population or transmission and at the same time vaccinate to keep the immunity levels high, then I think we have a chance of controlling dengue.”
Dr. Paz-Bailey concluded: “I do want to emphasize that we are excited about having these tools, because for years and years, we have had really limited options to prevent and control dengue. It’s an important addition to have the vaccine be approved to be used within the U.S., and it’s going to pave the road for future vaccines.”
Dr. Paz-Bailey and Dr. Ooi reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The vaccine is only to be used for children aged 9-16 who live in endemic areas and who have evidence with a specific diagnostic test of prior dengue infection.
Dengue is a mosquito-borne virus found throughout the world, primarily in tropical or subtropical climates. Cases had steadily been increasing to 5.2 million in 2019, and the geographic distribution of cases is broadening with climate change and urbanization. About half of the world’s population is now at risk.
The dengue virus has four serotypes. The first infection may be mild or asymptomatic, but the second one can be life-threatening because of a phenomenon called antibody-dependent enhancement.
The lead author of the new recommendations is Gabriela Paz-Bailey, MD, PhD, division of vector-borne diseases, dengue branch, CDC. She told this news organization that, during the second infection, when there are “low levels of antibodies from that first infection, the antibodies help the virus get inside the cells. There the virus is not killed, and that results in increased viral load, and then that can result in more severe disease and the plasma leakage” syndrome, which can lead to shock, severe bleeding, and organ failure. The death rate for severe dengue is up to 13%.
Previous infection with Zika virus, common in the same areas where dengue is endemic, can also increase the risk for symptomatic and severe dengue for subsequent infections.
In the United States, Puerto Rico is the main focus of control efforts because 95% of domestic dengue cases originate there – almost 30,000 cases between 2010 and 2020, with 11,000 cases and 4,000 hospitalizations occurring in children between the ages of 10 and 19.
Because Aedes aegypti, the primary mosquito vector transmitting dengue, is resistant to all commonly used insecticides in Puerto Rico, preventive efforts have shifted from insecticides to vaccination.
Antibody tests prevaccination
The main concern with the Sanofi’s dengue vaccine is that it could act as an asymptomatic primary dengue infection, in effect priming the body for a severe reaction from antibody-dependent enhancement with a subsequent infection. That is why it’s critical that the vaccine only be given to children with evidence of prior disease.
Dr. Paz-Bailey said: “The CDC came up with recommendations of what the performance of the test used for prevaccination screening should be. And it was 98% specificity and 75% sensitivity. ... But no test by itself was found to have a specificity of 98%, and this is why we’re recommending the two-test algorithm,” in which two different assays are run off the same blood sample, drawn at a prevaccination visit.
If the child has evidence of prior dengue, they can proceed with vaccination to protect against recurrent infection. Dengvaxia is given as a series of three shots over 6 months. Vaccine efficacy is 82% – so not everyone is protected, and additionally, that protection declines over time.
There is concern that it will be difficult to achieve compliance with such a complex regimen. Dr. Paz-Bailey said, “But I think that the trust in vaccines that is highly prevalent for [Puerto] Rico and trusting the health care system, and sort of the importance that is assigned to dengue by providers and by parents because of previous outbreaks and previous experiences is going to help us.” She added, “I think that the COVID experience has been very revealing. And what we have learned is that Puerto Rico has a very strong health care system, a very strong network of vaccine providers. ... Coverage for COVID vaccine is higher than in other parts of the U.S.”
One of the interesting things about dengue is that the first infection can range from asymptomatic to life-threatening. The second infection is generally worse because of this antibody-dependent enhancement phenomenon. Eng Eong Ooi, MD, PhD, professor of microbiology and immunology, National University of Singapore, told this news organization, “After you have two infections, you seem to be protected quite well against the remaining two [serotypes]. The vaccine serves as another episode of infection in those who had prior dengue, so then any natural infections after the vaccination in the seropositive become like the outcome of a third or fourth infection.”
Vaccination alone will not solve dengue. Dr. Ooi said, “There’s not one method that would fully control dengue. You need both vaccines as well as control measures, whether it’s Wolbachia or something else. At the same time, I think we need antiviral drugs, because hitting this virus in just one part of its life cycle wouldn’t make a huge, lasting impact.” Dr. Ooi added that as “the spread of the virus and the population immunity drops, you’re actually now more vulnerable to dengue outbreaks when they do get introduced. So, suppressing transmission alone isn’t the answer. You also have to keep herd immunity levels high. So if we can reduce the virus transmission by controlling either mosquito population or transmission and at the same time vaccinate to keep the immunity levels high, then I think we have a chance of controlling dengue.”
Dr. Paz-Bailey concluded: “I do want to emphasize that we are excited about having these tools, because for years and years, we have had really limited options to prevent and control dengue. It’s an important addition to have the vaccine be approved to be used within the U.S., and it’s going to pave the road for future vaccines.”
Dr. Paz-Bailey and Dr. Ooi reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM MMWR RECOMMENDATIONS AND REPORTS
Quebec plans to fine unvaccinated adults
The amount hasn’t been decided yet, but it will be “significant” and more than $100. More details will be released at a later date, The Associated Press reported.
“Those who refuse to get their first doses in the coming weeks will have to pay a new health contribution,” Premier Francois Legault said during a news conference.
Not getting vaccinated burdens the health care system, and not all residents should pay for it, he said. About 10% of adults in Quebec are unvaccinated, but they represent about 50% of intensive care patients.
“I think it’s reasonable a majority of the population is asking that there be consequences,” he said. “It’s a question of fairness for the 90% of the population that have made some sacrifices. We owe them.”
The fine will apply to those who don’t qualify for a medical exemption, Mr. Legault said.
Provinces across Canada have reported a surge in COVID-19 cases due to the Omicron variant, with Quebec being one of the hardest-hit, according to Reuters. The province is regularly recording the highest daily case count across the country.
Quebec also has announced a 10 p.m. to 5 a.m. curfew, the AP reported. Starting Jan. 18, liquor and cannabis stores in the province will require proof of vaccination, and shopping malls and hair salons could soon require them as well.
About a quarter of all Canadians live in Quebec, according to CNN. The province was one of the first in Canada to require proof of vaccination for residents to eat in restaurants, go to the gym, or attend sporting events.
Some European countries have announced fees for unvaccinated residents, the AP reported, but Quebec is the first in Canada to announce a financial penalty for those who don’t get a shot.
In Greece, people older than 60 have until Jan. 16 to receive the first dose, or they will be fined 100 euros for every month they remain unvaccinated, the AP reported.
Austria will impose fines up to 3,600 euros for those who don’t follow the vaccine mandate for ages 14 and older, which is slated to start in February.
In Italy, residents who are 50 and older are required to be vaccinated. In mid-February, those who are unvaccinated could be fined up to 1,600 euros if they enter their workplaces, the AP reported.
A version of this article first appeared on WebMD.com.
The amount hasn’t been decided yet, but it will be “significant” and more than $100. More details will be released at a later date, The Associated Press reported.
“Those who refuse to get their first doses in the coming weeks will have to pay a new health contribution,” Premier Francois Legault said during a news conference.
Not getting vaccinated burdens the health care system, and not all residents should pay for it, he said. About 10% of adults in Quebec are unvaccinated, but they represent about 50% of intensive care patients.
“I think it’s reasonable a majority of the population is asking that there be consequences,” he said. “It’s a question of fairness for the 90% of the population that have made some sacrifices. We owe them.”
The fine will apply to those who don’t qualify for a medical exemption, Mr. Legault said.
Provinces across Canada have reported a surge in COVID-19 cases due to the Omicron variant, with Quebec being one of the hardest-hit, according to Reuters. The province is regularly recording the highest daily case count across the country.
Quebec also has announced a 10 p.m. to 5 a.m. curfew, the AP reported. Starting Jan. 18, liquor and cannabis stores in the province will require proof of vaccination, and shopping malls and hair salons could soon require them as well.
About a quarter of all Canadians live in Quebec, according to CNN. The province was one of the first in Canada to require proof of vaccination for residents to eat in restaurants, go to the gym, or attend sporting events.
Some European countries have announced fees for unvaccinated residents, the AP reported, but Quebec is the first in Canada to announce a financial penalty for those who don’t get a shot.
In Greece, people older than 60 have until Jan. 16 to receive the first dose, or they will be fined 100 euros for every month they remain unvaccinated, the AP reported.
Austria will impose fines up to 3,600 euros for those who don’t follow the vaccine mandate for ages 14 and older, which is slated to start in February.
In Italy, residents who are 50 and older are required to be vaccinated. In mid-February, those who are unvaccinated could be fined up to 1,600 euros if they enter their workplaces, the AP reported.
A version of this article first appeared on WebMD.com.
The amount hasn’t been decided yet, but it will be “significant” and more than $100. More details will be released at a later date, The Associated Press reported.
“Those who refuse to get their first doses in the coming weeks will have to pay a new health contribution,” Premier Francois Legault said during a news conference.
Not getting vaccinated burdens the health care system, and not all residents should pay for it, he said. About 10% of adults in Quebec are unvaccinated, but they represent about 50% of intensive care patients.
“I think it’s reasonable a majority of the population is asking that there be consequences,” he said. “It’s a question of fairness for the 90% of the population that have made some sacrifices. We owe them.”
The fine will apply to those who don’t qualify for a medical exemption, Mr. Legault said.
Provinces across Canada have reported a surge in COVID-19 cases due to the Omicron variant, with Quebec being one of the hardest-hit, according to Reuters. The province is regularly recording the highest daily case count across the country.
Quebec also has announced a 10 p.m. to 5 a.m. curfew, the AP reported. Starting Jan. 18, liquor and cannabis stores in the province will require proof of vaccination, and shopping malls and hair salons could soon require them as well.
About a quarter of all Canadians live in Quebec, according to CNN. The province was one of the first in Canada to require proof of vaccination for residents to eat in restaurants, go to the gym, or attend sporting events.
Some European countries have announced fees for unvaccinated residents, the AP reported, but Quebec is the first in Canada to announce a financial penalty for those who don’t get a shot.
In Greece, people older than 60 have until Jan. 16 to receive the first dose, or they will be fined 100 euros for every month they remain unvaccinated, the AP reported.
Austria will impose fines up to 3,600 euros for those who don’t follow the vaccine mandate for ages 14 and older, which is slated to start in February.
In Italy, residents who are 50 and older are required to be vaccinated. In mid-February, those who are unvaccinated could be fined up to 1,600 euros if they enter their workplaces, the AP reported.
A version of this article first appeared on WebMD.com.
The limits of education
For more than a decade, studies on the dubious value of education in the face of vaccine refusal and hesitancy have been accumulating. But, too often, the research has been ignored by folks who believe that they can teach the “misinformed” into dropping their resistance. Among some circles education ranks right up there with apple pie and motherhood as one of the pillars of Americana. Those wedded to the education mantra may acknowledge that teaching and preaching hasn’t worked well in the past. But, they may claim it’s because we haven’t done enough of it or hit the right buttons. The notion that if we can just share the facts with the uninformed everything will be fine is a myth that obviously is going to die slowly.
In a recent op-ed piece in the New York Times two physicians at Harvard Medical School reported on their study of about three-quarters of a million children who were eligible to receive HPV vaccines (2021 Dec 21. “Facts alone aren’t going to win over the unvaccinated. This might,” Anupam B. Jena and Christopher M. Worsham). The researchers found that children whose mothers had been diagnosed with cervical cancer were no more likely to be immunized than those children whose mothers had not had the disease. Who could be better informed about risks and hazards of contracting HPV than women with cervical cancer? If the facts won’t motivate, where does that leave us?
Those of you born before 1960 may remember or at least have heard about a television show called “Truth or Consequences.” It was a silly farce of a game show which has no bearing on our nation’s crisis of widespread vaccine refusal. However, buried in its title is the answer. If the truth isn’t convincing the resistors, then the obvious choice is consequences.
I hope that you have discovered that same strategy when counseling parents of misbehaving children. Talk is cheap and often ineffective. Explaining the error of his ways to a child who probably already knows what he is doing wrong is a waste of everyone’s time and unpleasant for those within earshot. At some point, sooner better than later, it’s time to say there is going to be a consequence for this misbehavior – going home from the playground, spending a few minutes in time-out, removing a privilege, etc. If consequences are chosen well and instituted with a minimum of idle threats, they work.
And, we are beginning to see it work in the face of pandemic shot refusal. Here in Maine the governor mandated that all health care workers be vaccinated. There was plenty of gnashing of teeth and threats of mass job walk offs. And, there were a few hospital workers who quit, but in the end it worked.
The trick is choosing consequences that have some teeth and make sense. Clearly, some folks who have read about the consequences of not getting vaccinated and may have even lost family members to the disease don’t see those losses as significant consequences for whatever reason. The threat of losing a job is likely to get their attention.
Threats must be carried out even though they may be disruptive in the short term. The good thing about well-crafted mandates is that they can be a win-win for everyone. The vaccine resisters don’t need to admit they were wrong. “Those shots are B.S., but the governor made me do it.” The problem is finding leaders who understand that education has its limits and who have the courage to create and administer the consequences.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.
For more than a decade, studies on the dubious value of education in the face of vaccine refusal and hesitancy have been accumulating. But, too often, the research has been ignored by folks who believe that they can teach the “misinformed” into dropping their resistance. Among some circles education ranks right up there with apple pie and motherhood as one of the pillars of Americana. Those wedded to the education mantra may acknowledge that teaching and preaching hasn’t worked well in the past. But, they may claim it’s because we haven’t done enough of it or hit the right buttons. The notion that if we can just share the facts with the uninformed everything will be fine is a myth that obviously is going to die slowly.
In a recent op-ed piece in the New York Times two physicians at Harvard Medical School reported on their study of about three-quarters of a million children who were eligible to receive HPV vaccines (2021 Dec 21. “Facts alone aren’t going to win over the unvaccinated. This might,” Anupam B. Jena and Christopher M. Worsham). The researchers found that children whose mothers had been diagnosed with cervical cancer were no more likely to be immunized than those children whose mothers had not had the disease. Who could be better informed about risks and hazards of contracting HPV than women with cervical cancer? If the facts won’t motivate, where does that leave us?
Those of you born before 1960 may remember or at least have heard about a television show called “Truth or Consequences.” It was a silly farce of a game show which has no bearing on our nation’s crisis of widespread vaccine refusal. However, buried in its title is the answer. If the truth isn’t convincing the resistors, then the obvious choice is consequences.
I hope that you have discovered that same strategy when counseling parents of misbehaving children. Talk is cheap and often ineffective. Explaining the error of his ways to a child who probably already knows what he is doing wrong is a waste of everyone’s time and unpleasant for those within earshot. At some point, sooner better than later, it’s time to say there is going to be a consequence for this misbehavior – going home from the playground, spending a few minutes in time-out, removing a privilege, etc. If consequences are chosen well and instituted with a minimum of idle threats, they work.
And, we are beginning to see it work in the face of pandemic shot refusal. Here in Maine the governor mandated that all health care workers be vaccinated. There was plenty of gnashing of teeth and threats of mass job walk offs. And, there were a few hospital workers who quit, but in the end it worked.
The trick is choosing consequences that have some teeth and make sense. Clearly, some folks who have read about the consequences of not getting vaccinated and may have even lost family members to the disease don’t see those losses as significant consequences for whatever reason. The threat of losing a job is likely to get their attention.
Threats must be carried out even though they may be disruptive in the short term. The good thing about well-crafted mandates is that they can be a win-win for everyone. The vaccine resisters don’t need to admit they were wrong. “Those shots are B.S., but the governor made me do it.” The problem is finding leaders who understand that education has its limits and who have the courage to create and administer the consequences.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.
For more than a decade, studies on the dubious value of education in the face of vaccine refusal and hesitancy have been accumulating. But, too often, the research has been ignored by folks who believe that they can teach the “misinformed” into dropping their resistance. Among some circles education ranks right up there with apple pie and motherhood as one of the pillars of Americana. Those wedded to the education mantra may acknowledge that teaching and preaching hasn’t worked well in the past. But, they may claim it’s because we haven’t done enough of it or hit the right buttons. The notion that if we can just share the facts with the uninformed everything will be fine is a myth that obviously is going to die slowly.
In a recent op-ed piece in the New York Times two physicians at Harvard Medical School reported on their study of about three-quarters of a million children who were eligible to receive HPV vaccines (2021 Dec 21. “Facts alone aren’t going to win over the unvaccinated. This might,” Anupam B. Jena and Christopher M. Worsham). The researchers found that children whose mothers had been diagnosed with cervical cancer were no more likely to be immunized than those children whose mothers had not had the disease. Who could be better informed about risks and hazards of contracting HPV than women with cervical cancer? If the facts won’t motivate, where does that leave us?
Those of you born before 1960 may remember or at least have heard about a television show called “Truth or Consequences.” It was a silly farce of a game show which has no bearing on our nation’s crisis of widespread vaccine refusal. However, buried in its title is the answer. If the truth isn’t convincing the resistors, then the obvious choice is consequences.
I hope that you have discovered that same strategy when counseling parents of misbehaving children. Talk is cheap and often ineffective. Explaining the error of his ways to a child who probably already knows what he is doing wrong is a waste of everyone’s time and unpleasant for those within earshot. At some point, sooner better than later, it’s time to say there is going to be a consequence for this misbehavior – going home from the playground, spending a few minutes in time-out, removing a privilege, etc. If consequences are chosen well and instituted with a minimum of idle threats, they work.
And, we are beginning to see it work in the face of pandemic shot refusal. Here in Maine the governor mandated that all health care workers be vaccinated. There was plenty of gnashing of teeth and threats of mass job walk offs. And, there were a few hospital workers who quit, but in the end it worked.
The trick is choosing consequences that have some teeth and make sense. Clearly, some folks who have read about the consequences of not getting vaccinated and may have even lost family members to the disease don’t see those losses as significant consequences for whatever reason. The threat of losing a job is likely to get their attention.
Threats must be carried out even though they may be disruptive in the short term. The good thing about well-crafted mandates is that they can be a win-win for everyone. The vaccine resisters don’t need to admit they were wrong. “Those shots are B.S., but the governor made me do it.” The problem is finding leaders who understand that education has its limits and who have the courage to create and administer the consequences.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.
CDC: More kids hospitalized with COVID since pandemic began
Hospital admissions of U.S. children younger than 5 – the only group ineligible for vaccination – have reached their peak since the start of the pandemic, according to new data from the Centers for Disease Control and Prevention.
CDC Director Rochelle Walensky, MD, said the higher numbers show the importance of vaccination for all eligible groups.
“This is the highest number of pediatric hospitalizations we’ve seen throughout the pandemic, which we said about Delta until now,” she said at a CDC briefing Friday. “This very well may be that there are just more cases out there, and our children are more vulnerable when they have more cases surrounding them.”
Despite the skyrocketing admissions, hospitalizations are still relatively low for children, she said. The hospitalization rate for children under 5 is 4 in 100,000, and it’s about 1 in 100,000 in children 5-17.
Dr. Walensky said not all children are being hospitalized for COVID-19 – some are admitted for unrelated issues and test positive but don’t have symptoms.
“We are still learning more about the severity of Omicron in children,” she said, noting that just over 50% of children 12-18 are fully vaccinated, while only 16% of those ages 5-11 are fully vaccinated.
Friday’s teleconference was the first CDC briefing in several months and comes on the heels of recent guideline updates for testing and isolation that have left the American public dumbfounded. When asked why the briefing was held, Dr. Walensky said there had been interest in hearing more from the CDC, saying, “I anticipate this will be the first of many briefings.”
She also defended the confusing guideline changes, saying, “We’re in an unprecedented time with the speed of Omicron cases rising. … This is hard, and I am committed to continuing to improve as we learn more about the science and communicate that to you.”
A version of this article first appeared on WebMD.com.
Hospital admissions of U.S. children younger than 5 – the only group ineligible for vaccination – have reached their peak since the start of the pandemic, according to new data from the Centers for Disease Control and Prevention.
CDC Director Rochelle Walensky, MD, said the higher numbers show the importance of vaccination for all eligible groups.
“This is the highest number of pediatric hospitalizations we’ve seen throughout the pandemic, which we said about Delta until now,” she said at a CDC briefing Friday. “This very well may be that there are just more cases out there, and our children are more vulnerable when they have more cases surrounding them.”
Despite the skyrocketing admissions, hospitalizations are still relatively low for children, she said. The hospitalization rate for children under 5 is 4 in 100,000, and it’s about 1 in 100,000 in children 5-17.
Dr. Walensky said not all children are being hospitalized for COVID-19 – some are admitted for unrelated issues and test positive but don’t have symptoms.
“We are still learning more about the severity of Omicron in children,” she said, noting that just over 50% of children 12-18 are fully vaccinated, while only 16% of those ages 5-11 are fully vaccinated.
Friday’s teleconference was the first CDC briefing in several months and comes on the heels of recent guideline updates for testing and isolation that have left the American public dumbfounded. When asked why the briefing was held, Dr. Walensky said there had been interest in hearing more from the CDC, saying, “I anticipate this will be the first of many briefings.”
She also defended the confusing guideline changes, saying, “We’re in an unprecedented time with the speed of Omicron cases rising. … This is hard, and I am committed to continuing to improve as we learn more about the science and communicate that to you.”
A version of this article first appeared on WebMD.com.
Hospital admissions of U.S. children younger than 5 – the only group ineligible for vaccination – have reached their peak since the start of the pandemic, according to new data from the Centers for Disease Control and Prevention.
CDC Director Rochelle Walensky, MD, said the higher numbers show the importance of vaccination for all eligible groups.
“This is the highest number of pediatric hospitalizations we’ve seen throughout the pandemic, which we said about Delta until now,” she said at a CDC briefing Friday. “This very well may be that there are just more cases out there, and our children are more vulnerable when they have more cases surrounding them.”
Despite the skyrocketing admissions, hospitalizations are still relatively low for children, she said. The hospitalization rate for children under 5 is 4 in 100,000, and it’s about 1 in 100,000 in children 5-17.
Dr. Walensky said not all children are being hospitalized for COVID-19 – some are admitted for unrelated issues and test positive but don’t have symptoms.
“We are still learning more about the severity of Omicron in children,” she said, noting that just over 50% of children 12-18 are fully vaccinated, while only 16% of those ages 5-11 are fully vaccinated.
Friday’s teleconference was the first CDC briefing in several months and comes on the heels of recent guideline updates for testing and isolation that have left the American public dumbfounded. When asked why the briefing was held, Dr. Walensky said there had been interest in hearing more from the CDC, saying, “I anticipate this will be the first of many briefings.”
She also defended the confusing guideline changes, saying, “We’re in an unprecedented time with the speed of Omicron cases rising. … This is hard, and I am committed to continuing to improve as we learn more about the science and communicate that to you.”
A version of this article first appeared on WebMD.com.
Lack of high school education vaccine hesitancy predictor
Lack of a high school education is a predictor of whether a person will be resistant to getting the COVID-19 vaccine, a new study shows.
Researchers from the University of North Carolina looked at vaccination rates in 3,142 counties in the U.S. They compared them to population characteristics based on the CDC Social Vulnerability Index.
They found that more than half of the unvaccinated adults in the U.S. with strong vaccine hesitancy had a high school education or less. Vaccine hesitancy was defined as refusal to be vaccinated even if the COVID-19 vaccine was available.
The other main predictor for vaccine hesitancy was concern about vaccine availability and distribution, the researchers said.
“Our study suggests that low education levels are a major contributor to vaccine hesitancy and ultimately vaccination levels,” the authors wrote. The study was published in the American Journal of Infection Control. “Specifically, low vaccination levels were found in communities with a less educated population and with more concern about vaccine uptake capacity, suggesting that education is an ongoing challenge.”
“Our findings suggest that policy makers and community leaders should tailor vaccine information and efforts to those with limited education and specifically address knowledge concerns that are prevalent and likely more modifiable.”
The study was based on data gathered months ago. It says that as of May 9, 2021, 34.7% of the U.S. population was fully vaccinated and that 8% reported a strong unwillingness to get vaccinated.
At press time, the Centers for Disease Control and Prevention’s COVID Data Tracker showed that 62.5% of the U.S. population was fully vaccinated.
According to the study, other consistent characteristics of people who are vaccine hesitant are that they belong to a racial minority, are 65 or older, live in a household with children 18 or younger, or are unemployed.
When asked why they were vaccine hesitant, people gave these reasons: Lack of trust in COVID-19 vaccines (55%), concerns about side effects (48%), and lack of trust in government (46%).
Lack of access to vaccines, often cited in previous studies about resistance to other vaccines, was not cited as a reason for not getting the COVID-19 vaccine.
“COVID-19 vaccine hesitancy is a public health threat,” the researchers concluded. “Since education levels are not easily modifiable, our results suggest that policymakers would be best served by closing knowledge gaps to overcome negative perceptions of the vaccine through tailored interventions.”
A version of this article first appeared on WebMD.com.
Lack of a high school education is a predictor of whether a person will be resistant to getting the COVID-19 vaccine, a new study shows.
Researchers from the University of North Carolina looked at vaccination rates in 3,142 counties in the U.S. They compared them to population characteristics based on the CDC Social Vulnerability Index.
They found that more than half of the unvaccinated adults in the U.S. with strong vaccine hesitancy had a high school education or less. Vaccine hesitancy was defined as refusal to be vaccinated even if the COVID-19 vaccine was available.
The other main predictor for vaccine hesitancy was concern about vaccine availability and distribution, the researchers said.
“Our study suggests that low education levels are a major contributor to vaccine hesitancy and ultimately vaccination levels,” the authors wrote. The study was published in the American Journal of Infection Control. “Specifically, low vaccination levels were found in communities with a less educated population and with more concern about vaccine uptake capacity, suggesting that education is an ongoing challenge.”
“Our findings suggest that policy makers and community leaders should tailor vaccine information and efforts to those with limited education and specifically address knowledge concerns that are prevalent and likely more modifiable.”
The study was based on data gathered months ago. It says that as of May 9, 2021, 34.7% of the U.S. population was fully vaccinated and that 8% reported a strong unwillingness to get vaccinated.
At press time, the Centers for Disease Control and Prevention’s COVID Data Tracker showed that 62.5% of the U.S. population was fully vaccinated.
According to the study, other consistent characteristics of people who are vaccine hesitant are that they belong to a racial minority, are 65 or older, live in a household with children 18 or younger, or are unemployed.
When asked why they were vaccine hesitant, people gave these reasons: Lack of trust in COVID-19 vaccines (55%), concerns about side effects (48%), and lack of trust in government (46%).
Lack of access to vaccines, often cited in previous studies about resistance to other vaccines, was not cited as a reason for not getting the COVID-19 vaccine.
“COVID-19 vaccine hesitancy is a public health threat,” the researchers concluded. “Since education levels are not easily modifiable, our results suggest that policymakers would be best served by closing knowledge gaps to overcome negative perceptions of the vaccine through tailored interventions.”
A version of this article first appeared on WebMD.com.
Lack of a high school education is a predictor of whether a person will be resistant to getting the COVID-19 vaccine, a new study shows.
Researchers from the University of North Carolina looked at vaccination rates in 3,142 counties in the U.S. They compared them to population characteristics based on the CDC Social Vulnerability Index.
They found that more than half of the unvaccinated adults in the U.S. with strong vaccine hesitancy had a high school education or less. Vaccine hesitancy was defined as refusal to be vaccinated even if the COVID-19 vaccine was available.
The other main predictor for vaccine hesitancy was concern about vaccine availability and distribution, the researchers said.
“Our study suggests that low education levels are a major contributor to vaccine hesitancy and ultimately vaccination levels,” the authors wrote. The study was published in the American Journal of Infection Control. “Specifically, low vaccination levels were found in communities with a less educated population and with more concern about vaccine uptake capacity, suggesting that education is an ongoing challenge.”
“Our findings suggest that policy makers and community leaders should tailor vaccine information and efforts to those with limited education and specifically address knowledge concerns that are prevalent and likely more modifiable.”
The study was based on data gathered months ago. It says that as of May 9, 2021, 34.7% of the U.S. population was fully vaccinated and that 8% reported a strong unwillingness to get vaccinated.
At press time, the Centers for Disease Control and Prevention’s COVID Data Tracker showed that 62.5% of the U.S. population was fully vaccinated.
According to the study, other consistent characteristics of people who are vaccine hesitant are that they belong to a racial minority, are 65 or older, live in a household with children 18 or younger, or are unemployed.
When asked why they were vaccine hesitant, people gave these reasons: Lack of trust in COVID-19 vaccines (55%), concerns about side effects (48%), and lack of trust in government (46%).
Lack of access to vaccines, often cited in previous studies about resistance to other vaccines, was not cited as a reason for not getting the COVID-19 vaccine.
“COVID-19 vaccine hesitancy is a public health threat,” the researchers concluded. “Since education levels are not easily modifiable, our results suggest that policymakers would be best served by closing knowledge gaps to overcome negative perceptions of the vaccine through tailored interventions.”
A version of this article first appeared on WebMD.com.
FROM THE AMERICAN JOURNAL OF INFECTION CONTROL
Mayo Clinic fires 700 employees for refusing COVID vaccine
The medical center, which is Minnesota’s largest employer, has major campuses in Arizona, Florida, and Minnesota and operates hospitals in Iowa and Wisconsin.
Employees had until Jan. 3 to get vaccinated or receive approval for an exemption. On Jan. 4, the hospital fired those who didn’t meet the requirement, according to Action News Jax, a CBS affiliate in Florida.
The 700 employees make up about 1% of Mayo Clinic’s 73,000-person workforce. So far, none of the employees at the campus in Jacksonville, Fla., have been affected, the news outlet reported.
“Florida staff who are not in compliance with our vaccination program remain employed pending the outcome of litigation related to the Centers for Medicare & Medicaid Services requirements,” a Mayo Clinic spokesperson told Action News Jax.
The federal government and Florida remain at odds over vaccine mandates, and several lawsuits are winding through the court system. Florida Gov. Ron DeSantis signed legislation in November that bans private Florida employers from requiring all employees to get vaccinated and calls for various exemption options, according to The Florida Times-Union. The state law clashes with a federal rule that requires vaccinations for all health care workers at hospitals that receive Medicare and Medicaid funding.
The Mayo Clinic mandate required employees to receive at least one COVID-19 vaccine dose and not be “overdue” for a second dose, according to the statement. Only medical and religious exemptions were allowed, and most medical and religious exemptions were approved.
“While Mayo Clinic is saddened to lose valuable employees, we need to take all steps necessary to keep our patients, workforce, visitors, and communities safe,” Mayo Clinic wrote in its statement. “If individuals released from employment choose to get vaccinated at a later date, the opportunity exists for them to apply and return to Mayo Clinic for future job openings.”
With the latest surge in COVID-19 cases from the Omicron variant, the Mayo Clinic also encouraged unvaccinated people to get a shot and those who are eligible for a booster to get one “as soon as possible.”
“Based on science and data, it’s clear that vaccination keeps people out of the hospital and saves lives,” according to the statement. “That’s true for everyone in our communities – and it’s especially true for the many patients with serious or complex diseases who seek care at Mayo Clinic each day.”
A version of this article first appeared on WebMD.com.
The medical center, which is Minnesota’s largest employer, has major campuses in Arizona, Florida, and Minnesota and operates hospitals in Iowa and Wisconsin.
Employees had until Jan. 3 to get vaccinated or receive approval for an exemption. On Jan. 4, the hospital fired those who didn’t meet the requirement, according to Action News Jax, a CBS affiliate in Florida.
The 700 employees make up about 1% of Mayo Clinic’s 73,000-person workforce. So far, none of the employees at the campus in Jacksonville, Fla., have been affected, the news outlet reported.
“Florida staff who are not in compliance with our vaccination program remain employed pending the outcome of litigation related to the Centers for Medicare & Medicaid Services requirements,” a Mayo Clinic spokesperson told Action News Jax.
The federal government and Florida remain at odds over vaccine mandates, and several lawsuits are winding through the court system. Florida Gov. Ron DeSantis signed legislation in November that bans private Florida employers from requiring all employees to get vaccinated and calls for various exemption options, according to The Florida Times-Union. The state law clashes with a federal rule that requires vaccinations for all health care workers at hospitals that receive Medicare and Medicaid funding.
The Mayo Clinic mandate required employees to receive at least one COVID-19 vaccine dose and not be “overdue” for a second dose, according to the statement. Only medical and religious exemptions were allowed, and most medical and religious exemptions were approved.
“While Mayo Clinic is saddened to lose valuable employees, we need to take all steps necessary to keep our patients, workforce, visitors, and communities safe,” Mayo Clinic wrote in its statement. “If individuals released from employment choose to get vaccinated at a later date, the opportunity exists for them to apply and return to Mayo Clinic for future job openings.”
With the latest surge in COVID-19 cases from the Omicron variant, the Mayo Clinic also encouraged unvaccinated people to get a shot and those who are eligible for a booster to get one “as soon as possible.”
“Based on science and data, it’s clear that vaccination keeps people out of the hospital and saves lives,” according to the statement. “That’s true for everyone in our communities – and it’s especially true for the many patients with serious or complex diseases who seek care at Mayo Clinic each day.”
A version of this article first appeared on WebMD.com.
The medical center, which is Minnesota’s largest employer, has major campuses in Arizona, Florida, and Minnesota and operates hospitals in Iowa and Wisconsin.
Employees had until Jan. 3 to get vaccinated or receive approval for an exemption. On Jan. 4, the hospital fired those who didn’t meet the requirement, according to Action News Jax, a CBS affiliate in Florida.
The 700 employees make up about 1% of Mayo Clinic’s 73,000-person workforce. So far, none of the employees at the campus in Jacksonville, Fla., have been affected, the news outlet reported.
“Florida staff who are not in compliance with our vaccination program remain employed pending the outcome of litigation related to the Centers for Medicare & Medicaid Services requirements,” a Mayo Clinic spokesperson told Action News Jax.
The federal government and Florida remain at odds over vaccine mandates, and several lawsuits are winding through the court system. Florida Gov. Ron DeSantis signed legislation in November that bans private Florida employers from requiring all employees to get vaccinated and calls for various exemption options, according to The Florida Times-Union. The state law clashes with a federal rule that requires vaccinations for all health care workers at hospitals that receive Medicare and Medicaid funding.
The Mayo Clinic mandate required employees to receive at least one COVID-19 vaccine dose and not be “overdue” for a second dose, according to the statement. Only medical and religious exemptions were allowed, and most medical and religious exemptions were approved.
“While Mayo Clinic is saddened to lose valuable employees, we need to take all steps necessary to keep our patients, workforce, visitors, and communities safe,” Mayo Clinic wrote in its statement. “If individuals released from employment choose to get vaccinated at a later date, the opportunity exists for them to apply and return to Mayo Clinic for future job openings.”
With the latest surge in COVID-19 cases from the Omicron variant, the Mayo Clinic also encouraged unvaccinated people to get a shot and those who are eligible for a booster to get one “as soon as possible.”
“Based on science and data, it’s clear that vaccination keeps people out of the hospital and saves lives,” according to the statement. “That’s true for everyone in our communities – and it’s especially true for the many patients with serious or complex diseases who seek care at Mayo Clinic each day.”
A version of this article first appeared on WebMD.com.
COVID-19 vaccination has little impact on menstrual cycle
Women may rest a bit easier thanks to results from a study showing that vaccination against the SARS-CoV-2 virus has almost no impact on a woman’s menstrual cycle. The issue is significant, as regular menstruation is a sign of health and fertility, and fears of disturbances might increase vaccination hesitancy as COVID-19 cases continue to surge.
Alison Edelman, MD, MPH, a professor of obstetrics and gynecology at Oregon Health & Science University, Portland, led a group studying prospective data on almost 24,000 menstrual cycles reported by almost 4,000 U.S. women.
The investigators found that COVID-19 vaccination was associated with a less than 1-day change in cycle length for the menstrual cycles after the first and second inoculations, compared with prevaccine cycles. Vaccination had no effect on the actual number of days menstrual bleeding lasted.
The study looked at the menstrual patterns of women aged 18-45 years with normal cycle lengths of 24-38 days for the three consecutive cycles before the first vaccine dose and for three consecutive postvaccine cycles. The final sample included 2,403 vaccinated and 1,556 unvaccinated individuals.
In vaccinated women, the study initially found a slight average increase in cycle length after dose one of 71% of a day and 91% of a day after dose two. Following adjustments, those increases dropped to 64% of a day after the first dose and 79% of a day after the second dose.
In unvaccinated women, the study looked at six cycles over a similar time period and found no significant changes from baseline.
“Coronavirus disease 2019 vaccination is associated with a small change in cycle length but not menses length,” Dr. Edelman’s group concluded in Obstetrics and Gynecology.
In the rare instance that a woman received two vaccine doses within the same menstrual cycle, the change in length could increase to 2 days. These variations appear to resolve quickly, possibly as soon as the next cycle after vaccination and do not indicate any cause for long-term physical or reproductive health concern, according to the authors.
Reports by women on social media, however, have suggested that postvaccine menstrual disruptions are more common with, for example, heavier and breakthrough bleeding. But it appears such changes are temporary and resolve quickly.
“These findings are reassuring and validating,” Dr. Edelman said in an interview. On a population level, the changes indicate no cause for concern for long-term physical or reproductive health and no reason to avoid vaccination. “On a personal level, people want this information so they know what to expect when they get vaccinated, and not worry about a pregnancy scare or be disappointed if they were trying for pregnancy.”
According to the International Federation of Gynecologists and Obstetricians, variations in cycle length of fewer than 8 days are considered normal, said Christine Metz, PhD, a research biologist and a professor of molecular medicine at the Feinstein Institutes for Medical Research in Manhasset, N.Y. “Thus, the extra 17 hours added to the menstrual cycle length in the vaccination group in this study is well within the ‘normal’ range.”
In a group of about 1,600 menstruating women being studied at Dr. Metz’s center, some have anecdotally reported transient cycle changes post vaccination for COVID-19, including delays in menstruation onset and changes in bleeding patterns.
Exactly how vaccination might alter menstrual cycle length is not known and has not been studied with vaccination against other infections such as influenza and meningococcal disease.
“Many factors are known to affect menstrual cycle length including changes in diet, sleep, and exercise, as well as sickness, travel, and stress,” Dr. Metz said. The COVID-19 vaccines have affected people in different ways, with side effects ranging from injection-site pain to nausea, aches, fever, and fatigue. “Vaccination side effects, particularly if severe, could lead to changes in diet, exercise, and sleep, and feelings of sickness and/or stress.”
These stressors can alter hormone production and stability, as well as the body’s response to hormones such as estrogen, progesterone, follicle-stimulating hormone, luteinizing hormone, and other hormones associated with female reproduction. “Because these hormones regulate the menstrual cycle, variations in these hormones can either shorten or lengthen the cycle,” Dr. Metz explained.
More research needs to be done at the global level, according to the authors. “Questions remain about other possible changes in menstrual cycles, such as menstrual symptoms, unscheduled bleeding, and changes in the quality and quantity of menstrual bleeding.”
This research was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health’s Office of Research on Women’s Health. Dr. Edelman reported support from the American College of Obstetrics and Gynecology, the World Health Organization, Gynuity, and the Karolinska Institute as well as royalties from UpToDate. Other study authors reported similar relationships with not-for-profit and private-sector companies. Three coauthors are employees of Natural Cycles, a fertility tracking device that was used in the study. Dr. Metz disclosed no conflicts of interest with regard to her comments.
Women may rest a bit easier thanks to results from a study showing that vaccination against the SARS-CoV-2 virus has almost no impact on a woman’s menstrual cycle. The issue is significant, as regular menstruation is a sign of health and fertility, and fears of disturbances might increase vaccination hesitancy as COVID-19 cases continue to surge.
Alison Edelman, MD, MPH, a professor of obstetrics and gynecology at Oregon Health & Science University, Portland, led a group studying prospective data on almost 24,000 menstrual cycles reported by almost 4,000 U.S. women.
The investigators found that COVID-19 vaccination was associated with a less than 1-day change in cycle length for the menstrual cycles after the first and second inoculations, compared with prevaccine cycles. Vaccination had no effect on the actual number of days menstrual bleeding lasted.
The study looked at the menstrual patterns of women aged 18-45 years with normal cycle lengths of 24-38 days for the three consecutive cycles before the first vaccine dose and for three consecutive postvaccine cycles. The final sample included 2,403 vaccinated and 1,556 unvaccinated individuals.
In vaccinated women, the study initially found a slight average increase in cycle length after dose one of 71% of a day and 91% of a day after dose two. Following adjustments, those increases dropped to 64% of a day after the first dose and 79% of a day after the second dose.
In unvaccinated women, the study looked at six cycles over a similar time period and found no significant changes from baseline.
“Coronavirus disease 2019 vaccination is associated with a small change in cycle length but not menses length,” Dr. Edelman’s group concluded in Obstetrics and Gynecology.
In the rare instance that a woman received two vaccine doses within the same menstrual cycle, the change in length could increase to 2 days. These variations appear to resolve quickly, possibly as soon as the next cycle after vaccination and do not indicate any cause for long-term physical or reproductive health concern, according to the authors.
Reports by women on social media, however, have suggested that postvaccine menstrual disruptions are more common with, for example, heavier and breakthrough bleeding. But it appears such changes are temporary and resolve quickly.
“These findings are reassuring and validating,” Dr. Edelman said in an interview. On a population level, the changes indicate no cause for concern for long-term physical or reproductive health and no reason to avoid vaccination. “On a personal level, people want this information so they know what to expect when they get vaccinated, and not worry about a pregnancy scare or be disappointed if they were trying for pregnancy.”
According to the International Federation of Gynecologists and Obstetricians, variations in cycle length of fewer than 8 days are considered normal, said Christine Metz, PhD, a research biologist and a professor of molecular medicine at the Feinstein Institutes for Medical Research in Manhasset, N.Y. “Thus, the extra 17 hours added to the menstrual cycle length in the vaccination group in this study is well within the ‘normal’ range.”
In a group of about 1,600 menstruating women being studied at Dr. Metz’s center, some have anecdotally reported transient cycle changes post vaccination for COVID-19, including delays in menstruation onset and changes in bleeding patterns.
Exactly how vaccination might alter menstrual cycle length is not known and has not been studied with vaccination against other infections such as influenza and meningococcal disease.
“Many factors are known to affect menstrual cycle length including changes in diet, sleep, and exercise, as well as sickness, travel, and stress,” Dr. Metz said. The COVID-19 vaccines have affected people in different ways, with side effects ranging from injection-site pain to nausea, aches, fever, and fatigue. “Vaccination side effects, particularly if severe, could lead to changes in diet, exercise, and sleep, and feelings of sickness and/or stress.”
These stressors can alter hormone production and stability, as well as the body’s response to hormones such as estrogen, progesterone, follicle-stimulating hormone, luteinizing hormone, and other hormones associated with female reproduction. “Because these hormones regulate the menstrual cycle, variations in these hormones can either shorten or lengthen the cycle,” Dr. Metz explained.
More research needs to be done at the global level, according to the authors. “Questions remain about other possible changes in menstrual cycles, such as menstrual symptoms, unscheduled bleeding, and changes in the quality and quantity of menstrual bleeding.”
This research was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health’s Office of Research on Women’s Health. Dr. Edelman reported support from the American College of Obstetrics and Gynecology, the World Health Organization, Gynuity, and the Karolinska Institute as well as royalties from UpToDate. Other study authors reported similar relationships with not-for-profit and private-sector companies. Three coauthors are employees of Natural Cycles, a fertility tracking device that was used in the study. Dr. Metz disclosed no conflicts of interest with regard to her comments.
Women may rest a bit easier thanks to results from a study showing that vaccination against the SARS-CoV-2 virus has almost no impact on a woman’s menstrual cycle. The issue is significant, as regular menstruation is a sign of health and fertility, and fears of disturbances might increase vaccination hesitancy as COVID-19 cases continue to surge.
Alison Edelman, MD, MPH, a professor of obstetrics and gynecology at Oregon Health & Science University, Portland, led a group studying prospective data on almost 24,000 menstrual cycles reported by almost 4,000 U.S. women.
The investigators found that COVID-19 vaccination was associated with a less than 1-day change in cycle length for the menstrual cycles after the first and second inoculations, compared with prevaccine cycles. Vaccination had no effect on the actual number of days menstrual bleeding lasted.
The study looked at the menstrual patterns of women aged 18-45 years with normal cycle lengths of 24-38 days for the three consecutive cycles before the first vaccine dose and for three consecutive postvaccine cycles. The final sample included 2,403 vaccinated and 1,556 unvaccinated individuals.
In vaccinated women, the study initially found a slight average increase in cycle length after dose one of 71% of a day and 91% of a day after dose two. Following adjustments, those increases dropped to 64% of a day after the first dose and 79% of a day after the second dose.
In unvaccinated women, the study looked at six cycles over a similar time period and found no significant changes from baseline.
“Coronavirus disease 2019 vaccination is associated with a small change in cycle length but not menses length,” Dr. Edelman’s group concluded in Obstetrics and Gynecology.
In the rare instance that a woman received two vaccine doses within the same menstrual cycle, the change in length could increase to 2 days. These variations appear to resolve quickly, possibly as soon as the next cycle after vaccination and do not indicate any cause for long-term physical or reproductive health concern, according to the authors.
Reports by women on social media, however, have suggested that postvaccine menstrual disruptions are more common with, for example, heavier and breakthrough bleeding. But it appears such changes are temporary and resolve quickly.
“These findings are reassuring and validating,” Dr. Edelman said in an interview. On a population level, the changes indicate no cause for concern for long-term physical or reproductive health and no reason to avoid vaccination. “On a personal level, people want this information so they know what to expect when they get vaccinated, and not worry about a pregnancy scare or be disappointed if they were trying for pregnancy.”
According to the International Federation of Gynecologists and Obstetricians, variations in cycle length of fewer than 8 days are considered normal, said Christine Metz, PhD, a research biologist and a professor of molecular medicine at the Feinstein Institutes for Medical Research in Manhasset, N.Y. “Thus, the extra 17 hours added to the menstrual cycle length in the vaccination group in this study is well within the ‘normal’ range.”
In a group of about 1,600 menstruating women being studied at Dr. Metz’s center, some have anecdotally reported transient cycle changes post vaccination for COVID-19, including delays in menstruation onset and changes in bleeding patterns.
Exactly how vaccination might alter menstrual cycle length is not known and has not been studied with vaccination against other infections such as influenza and meningococcal disease.
“Many factors are known to affect menstrual cycle length including changes in diet, sleep, and exercise, as well as sickness, travel, and stress,” Dr. Metz said. The COVID-19 vaccines have affected people in different ways, with side effects ranging from injection-site pain to nausea, aches, fever, and fatigue. “Vaccination side effects, particularly if severe, could lead to changes in diet, exercise, and sleep, and feelings of sickness and/or stress.”
These stressors can alter hormone production and stability, as well as the body’s response to hormones such as estrogen, progesterone, follicle-stimulating hormone, luteinizing hormone, and other hormones associated with female reproduction. “Because these hormones regulate the menstrual cycle, variations in these hormones can either shorten or lengthen the cycle,” Dr. Metz explained.
More research needs to be done at the global level, according to the authors. “Questions remain about other possible changes in menstrual cycles, such as menstrual symptoms, unscheduled bleeding, and changes in the quality and quantity of menstrual bleeding.”
This research was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health’s Office of Research on Women’s Health. Dr. Edelman reported support from the American College of Obstetrics and Gynecology, the World Health Organization, Gynuity, and the Karolinska Institute as well as royalties from UpToDate. Other study authors reported similar relationships with not-for-profit and private-sector companies. Three coauthors are employees of Natural Cycles, a fertility tracking device that was used in the study. Dr. Metz disclosed no conflicts of interest with regard to her comments.
FROM OBSTETRICS & GYNECOLOGY
CDC panel recommends Pfizer COVID-19 boosters for ages 12-15
The CDC had already said 16- and 17-year-olds “may” receive a Pfizer booster but the new recommendation adds the 12- to 15-year-old group and strengthens the “may” to “should” for 16- and 17-year-olds.
The committee voted 13-1 to recommend the booster for ages 12-17. CDC Director Rochelle Walensky, MD, must still approve the recommendation for it to take effect.
The vote comes after the FDA on Jan. 3 authorized the Pfizer vaccine booster dose for 12- to 15-year-olds.
The FDA action updated the authorization for the Pfizer vaccine, and the agency also shortened the recommended time between a second dose and the booster to 5 months or more (from 6 months). A third primary series dose is also now authorized for certain immunocompromised children between 5 and 11 years old. Full details are available in an FDA news release.
The CDC on Jan. 4 also backed the shortened time frame and a third primary series dose for some immunocompromised children 5-11 years old. But the CDC delayed a decision on a booster for 12- to 15-year-olds until it heard from its Advisory Committee on Immunization Practices on Jan. 5.
The decision came as school districts nationwide are wrestling with decisions of whether to keep schools open or revert to a virtual format as cases surge, and as pediatric COVID-19 cases and hospitalizations reach new highs.
The only dissenting vote came from Helen Keipp Talbot, MD, associate professor of medicine at Vanderbilt University in Nashville, Tenn.
She said after the vote, “I am just fine with kids getting a booster. This is not me against all boosters. I just really want the U.S. to move forward with all kids.”
Dr. Talbot said earlier in the comment period, “If we divert our public health from the unvaccinated to the vaccinated, we are not going to make a big impact. Boosters are incredibly important but they won’t solve this problem of the crowded hospitals.”
She said vaccinating the unvaccinated must be the priority.
“If you are a parent out there who has not yet vaccinated your child because you have questions, please, please talk to a health care provider,” she said.
Among the 13 supporters of the recommendation was Oliver Brooks, MD, chief medical officer of Watts HealthCare Corporation in Los Angeles.
Dr. Brooks said extending the population for boosters is another tool in the toolbox.
“If it’s a hammer, we should hit that nail hard,” he said.
Sara Oliver, MD, ACIP’s lead for the COVID-19 work group, presented the case behind the recommendation.
She noted the soaring Omicron cases.
“As of Jan. 3, the 7-day average had reached an all-time high of nearly 500,000 cases,” Dr. Oliver noted.
Since this summer, she said, adolescents have had a higher rate of incidence than that of adults.
“The majority of COVID cases continue to occur among the unvaccinated,” she said, “with unvaccinated 12- to 17-year-olds having a 7-times-higher risk of testing positive for SARS-CoV-2 compared to vaccinated 12- to 17-year-olds. Unvaccinated 12- to 17-year-olds have around 11 times higher risk of hospitalization than vaccinated 12- to 17-year-olds.
“Vaccine effectiveness in adolescents 12-15 years old remains high,” Dr. Oliver said, but evidence shows there may be “some waning over time.”
Discussion of risk centered on myocarditis.
Dr. Oliver said myocarditis rates reported after the Pfizer vaccine in Israel across all populations as of Dec. 15 show that “the rates of myocarditis after a third dose are lower than what is seen after the second dose.”
A version of this article first appeared on WebMD.com.
The CDC had already said 16- and 17-year-olds “may” receive a Pfizer booster but the new recommendation adds the 12- to 15-year-old group and strengthens the “may” to “should” for 16- and 17-year-olds.
The committee voted 13-1 to recommend the booster for ages 12-17. CDC Director Rochelle Walensky, MD, must still approve the recommendation for it to take effect.
The vote comes after the FDA on Jan. 3 authorized the Pfizer vaccine booster dose for 12- to 15-year-olds.
The FDA action updated the authorization for the Pfizer vaccine, and the agency also shortened the recommended time between a second dose and the booster to 5 months or more (from 6 months). A third primary series dose is also now authorized for certain immunocompromised children between 5 and 11 years old. Full details are available in an FDA news release.
The CDC on Jan. 4 also backed the shortened time frame and a third primary series dose for some immunocompromised children 5-11 years old. But the CDC delayed a decision on a booster for 12- to 15-year-olds until it heard from its Advisory Committee on Immunization Practices on Jan. 5.
The decision came as school districts nationwide are wrestling with decisions of whether to keep schools open or revert to a virtual format as cases surge, and as pediatric COVID-19 cases and hospitalizations reach new highs.
The only dissenting vote came from Helen Keipp Talbot, MD, associate professor of medicine at Vanderbilt University in Nashville, Tenn.
She said after the vote, “I am just fine with kids getting a booster. This is not me against all boosters. I just really want the U.S. to move forward with all kids.”
Dr. Talbot said earlier in the comment period, “If we divert our public health from the unvaccinated to the vaccinated, we are not going to make a big impact. Boosters are incredibly important but they won’t solve this problem of the crowded hospitals.”
She said vaccinating the unvaccinated must be the priority.
“If you are a parent out there who has not yet vaccinated your child because you have questions, please, please talk to a health care provider,” she said.
Among the 13 supporters of the recommendation was Oliver Brooks, MD, chief medical officer of Watts HealthCare Corporation in Los Angeles.
Dr. Brooks said extending the population for boosters is another tool in the toolbox.
“If it’s a hammer, we should hit that nail hard,” he said.
Sara Oliver, MD, ACIP’s lead for the COVID-19 work group, presented the case behind the recommendation.
She noted the soaring Omicron cases.
“As of Jan. 3, the 7-day average had reached an all-time high of nearly 500,000 cases,” Dr. Oliver noted.
Since this summer, she said, adolescents have had a higher rate of incidence than that of adults.
“The majority of COVID cases continue to occur among the unvaccinated,” she said, “with unvaccinated 12- to 17-year-olds having a 7-times-higher risk of testing positive for SARS-CoV-2 compared to vaccinated 12- to 17-year-olds. Unvaccinated 12- to 17-year-olds have around 11 times higher risk of hospitalization than vaccinated 12- to 17-year-olds.
“Vaccine effectiveness in adolescents 12-15 years old remains high,” Dr. Oliver said, but evidence shows there may be “some waning over time.”
Discussion of risk centered on myocarditis.
Dr. Oliver said myocarditis rates reported after the Pfizer vaccine in Israel across all populations as of Dec. 15 show that “the rates of myocarditis after a third dose are lower than what is seen after the second dose.”
A version of this article first appeared on WebMD.com.
The CDC had already said 16- and 17-year-olds “may” receive a Pfizer booster but the new recommendation adds the 12- to 15-year-old group and strengthens the “may” to “should” for 16- and 17-year-olds.
The committee voted 13-1 to recommend the booster for ages 12-17. CDC Director Rochelle Walensky, MD, must still approve the recommendation for it to take effect.
The vote comes after the FDA on Jan. 3 authorized the Pfizer vaccine booster dose for 12- to 15-year-olds.
The FDA action updated the authorization for the Pfizer vaccine, and the agency also shortened the recommended time between a second dose and the booster to 5 months or more (from 6 months). A third primary series dose is also now authorized for certain immunocompromised children between 5 and 11 years old. Full details are available in an FDA news release.
The CDC on Jan. 4 also backed the shortened time frame and a third primary series dose for some immunocompromised children 5-11 years old. But the CDC delayed a decision on a booster for 12- to 15-year-olds until it heard from its Advisory Committee on Immunization Practices on Jan. 5.
The decision came as school districts nationwide are wrestling with decisions of whether to keep schools open or revert to a virtual format as cases surge, and as pediatric COVID-19 cases and hospitalizations reach new highs.
The only dissenting vote came from Helen Keipp Talbot, MD, associate professor of medicine at Vanderbilt University in Nashville, Tenn.
She said after the vote, “I am just fine with kids getting a booster. This is not me against all boosters. I just really want the U.S. to move forward with all kids.”
Dr. Talbot said earlier in the comment period, “If we divert our public health from the unvaccinated to the vaccinated, we are not going to make a big impact. Boosters are incredibly important but they won’t solve this problem of the crowded hospitals.”
She said vaccinating the unvaccinated must be the priority.
“If you are a parent out there who has not yet vaccinated your child because you have questions, please, please talk to a health care provider,” she said.
Among the 13 supporters of the recommendation was Oliver Brooks, MD, chief medical officer of Watts HealthCare Corporation in Los Angeles.
Dr. Brooks said extending the population for boosters is another tool in the toolbox.
“If it’s a hammer, we should hit that nail hard,” he said.
Sara Oliver, MD, ACIP’s lead for the COVID-19 work group, presented the case behind the recommendation.
She noted the soaring Omicron cases.
“As of Jan. 3, the 7-day average had reached an all-time high of nearly 500,000 cases,” Dr. Oliver noted.
Since this summer, she said, adolescents have had a higher rate of incidence than that of adults.
“The majority of COVID cases continue to occur among the unvaccinated,” she said, “with unvaccinated 12- to 17-year-olds having a 7-times-higher risk of testing positive for SARS-CoV-2 compared to vaccinated 12- to 17-year-olds. Unvaccinated 12- to 17-year-olds have around 11 times higher risk of hospitalization than vaccinated 12- to 17-year-olds.
“Vaccine effectiveness in adolescents 12-15 years old remains high,” Dr. Oliver said, but evidence shows there may be “some waning over time.”
Discussion of risk centered on myocarditis.
Dr. Oliver said myocarditis rates reported after the Pfizer vaccine in Israel across all populations as of Dec. 15 show that “the rates of myocarditis after a third dose are lower than what is seen after the second dose.”
A version of this article first appeared on WebMD.com.